Journal of Medical Engineering & Technology, Volume 16, Number 3 (May/June 1992), pages 107-111
Medical device regulations in the New Europe G. R. Higson
Specific regulatory requirements
Medical Technology Consultants Europe Ltd.. Arndale House, The Precinct, Egham, Surrcy TWZO SHN, LJK. Country
J Med Eng Technol Downloaded from informahealthcare.com by Nyu Medical Center on 07/03/15 For personal use only.
We are now in 1992, theyear of the 'Completion of the Internal Market'. Big changes in the ways in which medical devices will be controlled in Europe are on the way, but many healthcare professionals are unaware of these changes and what they will mean to them. This article explains the moves lhat are now under way to harmonize medical device legislation throughout Europe and the many features, new to the UK, that they will introduce.
Sterile product
Electromedical
Clinical trials
Austria Bclgium
X
Finland Frdncc
X
X X X X
X
X
X
X
X
X X
X
ICCkdnd
Background-a
single market by 1992
The European Community (EC) was founded in 1957 by five countries to create a Common Market, i.e. a market with no barriers to trade betwccn its members. The Community grew to 12 members, but although many internal barriers were removed or reduced, others appeared in their place. Most of these resulted from national laws regulating the safety of products of all kinds. Article 36 of the Treaty of Rome allows national legislation to be introduced where this is to protect safety and health. Many new laws have appeared under the shield of Article 36, and medical devices have been no exception. Most of the countries of Europe have some legislation affecting medical devices and these differ both in scopc and details. This means that much time and expense is involved in satisfying all thc diffrrent requirements that affect the marketing of a device in Europe. Some idea of the variety of rulcs in forcc at present is given by figure 1. This picture is repeated for products of all kinds and it is estimated that some L25 billion per annum is lost by European traders in overcoming internal barriers to trade[ 11. Both industry and governments have rccognized the need to eliminate this wastage if Europe is to compete against the USA and Japan. Of course, the Treaty of Rome, which founded the European Community, provided for eliminating these internal barriers by introducing dircctivcs to harmonizc the divergent national laws. The process was very inefficient, though, because of the technical detail that had to be incorporated in the directives and the need for unanimity between all the European Community members. (A directive is a community legal act, enacted by the Council of Ministers, which obliges Member States to harmonize their national laws, regulations and administrative measures with thc requirements of the directive.)
Labelling and packaging
(X)
Grcccc
Italy
(XI
X
Dcnmark Gcrmany
Distributors
X
X
X
Luxcmhciui
Ncthcrland:
X
Norway
X
X X
(XI
X X
POrtUgdl
Rcpuhlic (1' lrcland Spain
X
X
Swcdcn
X
X
X
X
X
Switzcrlanc Unitcd Kingdom
X
(XI
(X)
Figure I . Current regulatory requirements f o r medical devices (Parentheses indicate a quasi-regulatory regime or slrong code of praclice.)
In the 1980s it was recognized that the situation was not improving and a major study of the problem resulted in a White Paper published by the European Commission in June 1985 [2]. This sct out a programme of some 300 directives to harmonizc conflicting national legislation in key segments, and established a timetable which would bring these into cffcct by 31 Dcccmber 1992. This process is known as 'Completing the Single Internal Market', defined as making the EC an area in which there is free movement of goods, people and capital. In order to achieve this programme, two important changes to the process had to be made. One of these was to simplify thc way in which directives wcrc constructed. This is known as the 'New Approach', which is explained in detail below. The other significant change was the signing of thc Single European Act in 1986, under which the Member States gave up their right of veto over Single Market legislation. Under this Act, harmonizing directives can be approved by a weighted majority of votes. These two steps changed the pace of introduction of 107
C.
R. Higson Medical device regulations in the New Europe
directives dramatically. By the end of February 1992, of the 282 directives now decided on for the 1992 programme: 213 had been adopted 68 were in process and one is yet to be proposed.
The ‘New Approach’ to technical harmonization and standards
J Med Eng Technol Downloaded from informahealthcare.com by Nyu Medical Center on 07/03/15 For personal use only.
It is important to understand the basic principles of the ‘New Approach’. They are laid down in a Council Resolution of 7 May 1985 [3] w d apply to all EC legislation on industrial products, including medical devices. (1) Directives will not contain detailed technical provisions. Instead, they will list ‘essential requirements’ (ERs) with which products must comply. The ERs have force of law in that they become legally binding and enforceable obligations when transposed into national law. (2) Detailed technical provisions will be contained in harmonized standards adopted by the European standards organizations (CEN and CENELEC) . (3) Standards are voluntary, but a product that conforms to them is presumed to comply with the corresponding ERs. This confers a quasi-obligatory status on the harmonized technical standards, because of the implication that demonstrating compliance with ERs directly is much more difficult than demonstrating compliance with standards. (4) A product that complies with the requirements of a directive is in free circulation, i.e. authorities of a Member State may not stop its entry in normal circumstances.
The enormous importance assumed by standards in this process is obvious. We will return to this issue later. In practice, the manufacturer must be able to demonstrate that his product complies with the ERs by a method appropriate to the product. T h e method or methods will be laid down in individual directives and must be chosen from a menu of ‘conformity assessment procedures’ laid down by the Council. The methods range from a manufacturer’s declaration to complete pre-market test and approval by an authorized third party. The third parties, known as ‘Notified Bodies’, will be appointed by Member States and their names will be published in the OfJicialJournal of the European Communities. A manufacturer is free to go to any Notified Body in any country if the conformity assessment procedure for his product requires third party intervention. A product which complies with the ERs and which has been through the appropriate conformity assessment procedure is marked with a CE mark. A product marked in this way can be sold throughout the European Community without meeting any further regulatory hurdles. 108
The regulatory scheme for medical devices Harmonizing directives are intended literally to harmonize different or even conflicting national regulations. In the case of medical devices the Commission soon appreciated that the variation in national approaches was so great that no compromise system could be devised, and that the only thing to do was to develop completely fresh rules which would recognize existing approaches as far as possible, and which would cover all medical devices. The entire population of medical devices is divided into three groups covered by three separate directives: ( 1 ) Active implantable medical devices (AIMD), i.e. pacemakers, implantable drug pumps, neurostimulators, cochlear implants, etc. (This directive [4] was adopted in 1990 and comes into force on 1 January 1993. This document sets thc pattern for the other two directives.) (2) In vitro diagnostic devices (IVD), i.e. laboratory analysers, reagents, kits, etc. (This is at a very early stage.) (3) Medical devices (MD), i.c. any medical device which is not an AIMD or an IVD.
The active implants directive is the only one to meet the Community’s 1992 schedule. Member States are required to publish their national laws implementing this directive by 1 July 1992, but as yet none have done so. Draft laws have been issued by The Netherlands, Spain and Belgium, and the U K is expected to publish draft proposals soon. No Notified Bodies have yet been announced, and that remains a difficulty for manufacturers planning to comply with this directive at an early date. This directive applies to only a small number of devices, and so will not be discussed further in this article. Its provisions arc essentially identical with those applying to Class I11 devices in the Medical Device Directive (MDD-see below), which will be described in some detail. The IVD directive will also be skipped over as therc is, as yet, no draft directive available. The Commission has issued a discussion paper in which it is suggested that most IVD devices will be treated similarly to Class I devices in the MDD, while a small number will be subject to more stringent controls probably similar to those of Class IIb.
The draft Medical Device Directive After some 3 years of preparation the Commission made a formal proposal for a directive covering all medical devices other than active implants or IVDs on 30 August 1991 [5]. There are 24 Articles and 10 Annexes in the Directive. All are important, but the essence of the new regulatory system is contained in the following Articles and Annexes:
J Med Eng Technol Downloaded from informahealthcare.com by Nyu Medical Center on 07/03/15 For personal use only.
G.R. Higson Medical
device rrgulations in the New Europe
Scope and deJinition Article I The Directive applies to all medical devices and accessories. Article 2 Member States must make it illegal for medical devices to be marketed and used if they are not safe. Article 3 A safe medical devicc is one which complies with the Essential Requirements contained in Annex 1. Article 5 Devices complying with harmonized standards are deemed to comply with the Essential Requirements. Article I I Devices must go through a procedure (Annexes 2-7) to show that they conform to the Essential Requirements. The procedure depends on the Class of the device. Article 9 Devices are placed in Class I, IIa, IIb or I11 according to the rules given in Annex 9. Article I7 A device which complies with the Essential Requirements and has gone through the appropriate procedure must bear a C E mark. Article 4 Devices bearing a C E mark may circulate freely throughout the Community. Annex I-Essential Requirements There are six general requirements and 40 particular requirements. These are written in fairly general terms and for most of them standards are needed to provide the technical detail which designers and inspectors need. An outline of the Essential Requirements is given in figure 2.
1-6
0
0
Annexes 2-7-Con f o r m i Q assessment When the class of a medical device is known, the conformity assessment procedure which must be followed can be determined. The procedures, or components of the procedures, are described in detail in Annexes 2-7. Class I is the easiest, as that allows a manufacturer’s declaration. For all other classes there is intervention by a Notified Body. Class I11 is the most difficult because that requires pre-market approval of every single kind of device. The procedures for the four classes
Pcrf~irmancc Benefits must outweigh any side cffccts
Rules 1-4
6
used for storing body fluid connected to an active device in Class Ilat filtration of body fluids modification of body fluids some wound dressings
-
Biocnmpitihilily Drugldcvicc cumhinations
Stcriliiatiiin validatiiin Packaging
Nan-invasive devices Class I except:
-
-
Infcctiun and micrirhial ciintaminatiiin 0
0
An outline of the classification rules is given in figure 3 but, of course, to be certain about the classification of a device, Annex 9 must be studied in its entirety with great care.
Chemical and physicil priipcrtics 0
x
The classification scheme for non-active (non-powered) medical devices is based primarily on the sensitivity of the part of the body where the device is used. For active (powered) medical devices the classification scheme is based primarily on the emission of energy, or the delivery of substances, by the device.
Ccncral rcquircmcnls 0
7
Annex 9-ClassiJicalion rules It is necessary to provide some degree of proof that a device complies with Essential Requirements before a C E mark is applied. Because of the all-embracing nature of the MDD, there is no one conformity assessment procedure that is suitable for all products. Products are therefore divided into four classes according to the rules contained in Annex 9. A different conformity assessment procedure applies depending on the class into which the device falls.
5
Conncctiiins EMC susccptihility Firc and cxplosiiin
Transient use Most other applications 6 8
0 0
Rdusable surgical instruments Transient or short-term use (generally) Long-term use (generally) Contact with CCS or CNS
Accuracy and stahility Ldhclling Instructions fiir uhc
Prutcction against radiatiiin
9
Rcquircmcnts for mcdicdl dcviccs ciinncctcd o r equipped with an energy sourcc 0
0 0 0
13
S11ftwarc Alarms EMC cmissiiin Electric shock Contrul i i f delivery (if cncrgy or suhstanccs
Information supplicd hy the manufacturcr 0 0
Lahclling Instructitins for ubc
Figure 2. An oulline of the Essential Requirements for medical devices (Annex I of the MDD).
Class I Class Ila Class Ilb Class 111
Active therapeutic devices supplying energy or substances
-
not potentially dangerous potentially dangerous
Class IIa Class Ilb
10
Active diagnostic devices supplying energy or monitoring vital signs
Class Ila
II
Active devices not uivered hy Rules
-
tii
0
Class I Class Ila
Surgically invasive devices
Dcviccs with a mcasuring function
0
Class Ila Class IIb Class IIa + IIb
Devices invasive with respect to natural body orifices
Ciinstruction and cnvirirnmcntal properties 0 0 0
Class Ila Class IIa
9
I2 13
01
10
Class I
Devices incorporating a hiuavailahle drug
Class 111
Contraceptive devices
Class Ilh
Figure 3. An outline of the classijication rules for medical devices (Annex 9 of the MDD). 109
G. R. Higson Medical device regulations in the New Europe
The effects of the Medical Device Directive This Directive will, of course, bear primarily on manufacturers, but it will effect NHS users in several ways.
Hold tcchnical documentation
Hold technical documentation
EN 29002'Audit of sterilization/ measuring features
Verification by Notifid Body of sterilization/
J Med Eng Technol Downloaded from informahealthcare.com by Nyu Medical Center on 07/03/15 For personal use only.
Figure 4. Confonnig assessment proceduresfor Class I medical devices plus particular requirements.
E l Device
docMIentatmn Notified Body I
I
Figure 5. Confonnig assessment proceduresfor class IIa medical &rites plus particular requirements.
Notified Body EN 29002. Audit by Notified Body
EN 29003' Audit by N o t i f d Body
1-
-1
Product Verification by Notified Body
CEMark
Figure 6. Conformi& assessmentproceduresfor class IIb medical dcvices plus particular requirements.
I
Device
I
Hospitals inventing new devices or modifying existing devices are not manufacturers in the sense of this Directive as long as the devices are for their own use and are not sold to another user. The requirements of the Directive do not apply, therefore, but it would be foolish indeed for any NHS medical engineer not to satisfy himself that any device he has designed or modified complies with the Essential Requirements. The Product Liability Directive, implemented in the UK by the Consumer Protection Act 1987, would certainly regard him as a producer and, in the event of an incident, failure to comply with the Essential Requirements would make a defence very difficult. As soon as the Directive comes into effect (probably in July 1994) CE-marked products will begin to appear. Salesmen will no doubt be anxious to point out the superiority of their CE-marked product over a competitor which does not have the mark. This will not necessarily be correct. During the 3-year transition period it will be permissible to sell devices which comply with the national laws in force today-in the UK, no law at all. Products which are perfectly acceptable will continue to be sold without a CE mark. I t may be that the manufacturer has simply been slow to wake up to the existence of the Directive, he may be in a queue for the attention of a Notified Body, or the product may be one that will be withdrawn from the market before the end of the transition period.
At the end of the transition period (probably June 1997) only CE-marked products may remain on the market or may be used. What does it mean for a medical device to have a CE mark? It means that the device complies with the ERs-in most cases this will mean compliance with one or more harmonized standards. Harmonized standards are now being written in the European standards bodies CEN and CENELEC, or are being taken from international standards written in I S 0 or IEC.
by Notified Body I
V l
p G q
Figure 7. Conformi& assessment proceduresfor Class III medical devices plus particular requirements. are shown in figures 4-7. It will be seen that in every case the manufacturer has some choice in the procedure he wishes to follow. 110
The value of the C E mark will relate directly to the quality of the harmonized standards. Full participation by medical device users is essential if we are to have good standards. Both CEN and CENELEC have very active programmes to produce the standards needed by the Directive and more user input is desperately needed. Contact the BSI for more information. Some users, particularly medical users, are likely to find themselves involved in the assessment of products for CE marking. Manufacturers will be required to produce clinical evidence of the safety and performance of Class 111 devices, implants and possibly some other devices.
G.R. Higson Medical device rrgulations in
tlic New Europe
The Notified Bodies will have to call on the expertise of clinical users to help them evaluate this evidence.
J Med Eng Technol Downloaded from informahealthcare.com by Nyu Medical Center on 07/03/15 For personal use only.
Manufacturers will, of course, need to call on the expertise of users to help gather such evidence. Many readers will bc accustomed to carrying out clinical trials on new devices either on behalf of manufacturers or on devices of thcir own invention. Take note that the conduct of clinical trials will be rigidly controllcd in future. The Directive stipulates that clinical investigations must be carried out in accordance with the provisions of Annex 10. I n practice this will mean in accordance with the forthcoming European standard EN540 which is currently with national standards bodies for comment. Furthermore, if the device is in Class 111 or is an implant in Class IIa or Class IIb, the trial cannot be carried out without notifying thc Department of Health. Full details of the trial must be submitted to the Department and the trial may be commenced only if there is no reaction from the Department after a consideration period currently standing at 45 days. These drastic changes from current practice must be understood by all those involved in thc development of new medical devices or the conduct of clinical trials. Another new feature of this Directive which will make demands on NHS users is the requirement for postmarket surveillance and incident reporting. Manufacturers of all Class I1 and Class 111 devices are required to give an undertaking, during thc conformity assessment procedure, that they will notify the national authorities of thc following: Any deterioriation in the characteristics and/or performancc of the dcvicc, as well as any inaccuracies in the instruction leaflet, which might lead to or might have led to the death of a patient or user or to a serious deterioration in their state of health.
(2) Any technical or medical reason connected with the device leading to recall of devices of the same type by the manufacturer. In addition, manufacturers of Class I I b and Class I11 devices are required to set up a post-market surveillance system. Detailed guidance on the operation of the reporting and post-market surveillance systems is now being prepared by the Commission. What is already clear is that manufacturers will be unable to discharge these obligations without cooperation from NHS users. This Directive is now under discussion in the European Parliament, the Economic and Social Committee and an expert Working Group set up by the Council of Ministers (which will have to vote this Directive into law). Public discussion of the sweeping changes which it will introduce has been extremely limited, and participation by the professions all but non-existent. Even at this late stage it is not too late for professional views to be expressed to the Medical Devices Directorate of the Department of Health. However, it may be more realistic to urge more active participation by professional users of medical devices in the drafting of the law that will bring this Directive into effect in the UK, in publicizing the Directive and its consequenccs and, most importantly of all, in the preparation of the standards with which medical devices will have to comply.
References I . Cecchini, P (1988) The European Challenge 1992 (Wildwood House, Gower House, Aldershot, UK). 2. Commission of the European Communities (1985) White Paper on Completing the Single Internal Market by 1992. 3. Council Resolution 85/C 136/01 (1985) EC Ofjcial Journal C 136. 4. Council Directive 90/385 (1990) EC OficialJournal L189. 5. COM(91) 287 (1991) EC Ofjcial Journal C237.
111
Medical device regulations in the New Europe G. R. Higson
Specific regulatory requirements
Medical Technology Consultants Europe Ltd.. Arndale House, The Precinct, Egham, Surrcy TWZO SHN, LJK. Country
J Med Eng Technol Downloaded from informahealthcare.com by Nyu Medical Center on 07/03/15 For personal use only.
We are now in 1992, theyear of the 'Completion of the Internal Market'. Big changes in the ways in which medical devices will be controlled in Europe are on the way, but many healthcare professionals are unaware of these changes and what they will mean to them. This article explains the moves lhat are now under way to harmonize medical device legislation throughout Europe and the many features, new to the UK, that they will introduce.
Sterile product
Electromedical
Clinical trials
Austria Bclgium
X
Finland Frdncc
X
X X X X
X
X
X
X
X
X X
X
ICCkdnd
Background-a
single market by 1992
The European Community (EC) was founded in 1957 by five countries to create a Common Market, i.e. a market with no barriers to trade betwccn its members. The Community grew to 12 members, but although many internal barriers were removed or reduced, others appeared in their place. Most of these resulted from national laws regulating the safety of products of all kinds. Article 36 of the Treaty of Rome allows national legislation to be introduced where this is to protect safety and health. Many new laws have appeared under the shield of Article 36, and medical devices have been no exception. Most of the countries of Europe have some legislation affecting medical devices and these differ both in scopc and details. This means that much time and expense is involved in satisfying all thc diffrrent requirements that affect the marketing of a device in Europe. Some idea of the variety of rulcs in forcc at present is given by figure 1. This picture is repeated for products of all kinds and it is estimated that some L25 billion per annum is lost by European traders in overcoming internal barriers to trade[ 11. Both industry and governments have rccognized the need to eliminate this wastage if Europe is to compete against the USA and Japan. Of course, the Treaty of Rome, which founded the European Community, provided for eliminating these internal barriers by introducing dircctivcs to harmonizc the divergent national laws. The process was very inefficient, though, because of the technical detail that had to be incorporated in the directives and the need for unanimity between all the European Community members. (A directive is a community legal act, enacted by the Council of Ministers, which obliges Member States to harmonize their national laws, regulations and administrative measures with thc requirements of the directive.)
Labelling and packaging
(X)
Grcccc
Italy
(XI
X
Dcnmark Gcrmany
Distributors
X
X
X
Luxcmhciui
Ncthcrland:
X
Norway
X
X X
(XI
X X
POrtUgdl
Rcpuhlic (1' lrcland Spain
X
X
Swcdcn
X
X
X
X
X
Switzcrlanc Unitcd Kingdom
X
(XI
(X)
Figure I . Current regulatory requirements f o r medical devices (Parentheses indicate a quasi-regulatory regime or slrong code of praclice.)
In the 1980s it was recognized that the situation was not improving and a major study of the problem resulted in a White Paper published by the European Commission in June 1985 [2]. This sct out a programme of some 300 directives to harmonizc conflicting national legislation in key segments, and established a timetable which would bring these into cffcct by 31 Dcccmber 1992. This process is known as 'Completing the Single Internal Market', defined as making the EC an area in which there is free movement of goods, people and capital. In order to achieve this programme, two important changes to the process had to be made. One of these was to simplify thc way in which directives wcrc constructed. This is known as the 'New Approach', which is explained in detail below. The other significant change was the signing of thc Single European Act in 1986, under which the Member States gave up their right of veto over Single Market legislation. Under this Act, harmonizing directives can be approved by a weighted majority of votes. These two steps changed the pace of introduction of 107
C.
R. Higson Medical device regulations in the New Europe
directives dramatically. By the end of February 1992, of the 282 directives now decided on for the 1992 programme: 213 had been adopted 68 were in process and one is yet to be proposed.
The ‘New Approach’ to technical harmonization and standards
J Med Eng Technol Downloaded from informahealthcare.com by Nyu Medical Center on 07/03/15 For personal use only.
It is important to understand the basic principles of the ‘New Approach’. They are laid down in a Council Resolution of 7 May 1985 [3] w d apply to all EC legislation on industrial products, including medical devices. (1) Directives will not contain detailed technical provisions. Instead, they will list ‘essential requirements’ (ERs) with which products must comply. The ERs have force of law in that they become legally binding and enforceable obligations when transposed into national law. (2) Detailed technical provisions will be contained in harmonized standards adopted by the European standards organizations (CEN and CENELEC) . (3) Standards are voluntary, but a product that conforms to them is presumed to comply with the corresponding ERs. This confers a quasi-obligatory status on the harmonized technical standards, because of the implication that demonstrating compliance with ERs directly is much more difficult than demonstrating compliance with standards. (4) A product that complies with the requirements of a directive is in free circulation, i.e. authorities of a Member State may not stop its entry in normal circumstances.
The enormous importance assumed by standards in this process is obvious. We will return to this issue later. In practice, the manufacturer must be able to demonstrate that his product complies with the ERs by a method appropriate to the product. T h e method or methods will be laid down in individual directives and must be chosen from a menu of ‘conformity assessment procedures’ laid down by the Council. The methods range from a manufacturer’s declaration to complete pre-market test and approval by an authorized third party. The third parties, known as ‘Notified Bodies’, will be appointed by Member States and their names will be published in the OfJicialJournal of the European Communities. A manufacturer is free to go to any Notified Body in any country if the conformity assessment procedure for his product requires third party intervention. A product which complies with the ERs and which has been through the appropriate conformity assessment procedure is marked with a CE mark. A product marked in this way can be sold throughout the European Community without meeting any further regulatory hurdles. 108
The regulatory scheme for medical devices Harmonizing directives are intended literally to harmonize different or even conflicting national regulations. In the case of medical devices the Commission soon appreciated that the variation in national approaches was so great that no compromise system could be devised, and that the only thing to do was to develop completely fresh rules which would recognize existing approaches as far as possible, and which would cover all medical devices. The entire population of medical devices is divided into three groups covered by three separate directives: ( 1 ) Active implantable medical devices (AIMD), i.e. pacemakers, implantable drug pumps, neurostimulators, cochlear implants, etc. (This directive [4] was adopted in 1990 and comes into force on 1 January 1993. This document sets thc pattern for the other two directives.) (2) In vitro diagnostic devices (IVD), i.e. laboratory analysers, reagents, kits, etc. (This is at a very early stage.) (3) Medical devices (MD), i.c. any medical device which is not an AIMD or an IVD.
The active implants directive is the only one to meet the Community’s 1992 schedule. Member States are required to publish their national laws implementing this directive by 1 July 1992, but as yet none have done so. Draft laws have been issued by The Netherlands, Spain and Belgium, and the U K is expected to publish draft proposals soon. No Notified Bodies have yet been announced, and that remains a difficulty for manufacturers planning to comply with this directive at an early date. This directive applies to only a small number of devices, and so will not be discussed further in this article. Its provisions arc essentially identical with those applying to Class I11 devices in the Medical Device Directive (MDD-see below), which will be described in some detail. The IVD directive will also be skipped over as therc is, as yet, no draft directive available. The Commission has issued a discussion paper in which it is suggested that most IVD devices will be treated similarly to Class I devices in the MDD, while a small number will be subject to more stringent controls probably similar to those of Class IIb.
The draft Medical Device Directive After some 3 years of preparation the Commission made a formal proposal for a directive covering all medical devices other than active implants or IVDs on 30 August 1991 [5]. There are 24 Articles and 10 Annexes in the Directive. All are important, but the essence of the new regulatory system is contained in the following Articles and Annexes:
J Med Eng Technol Downloaded from informahealthcare.com by Nyu Medical Center on 07/03/15 For personal use only.
G.R. Higson Medical
device rrgulations in the New Europe
Scope and deJinition Article I The Directive applies to all medical devices and accessories. Article 2 Member States must make it illegal for medical devices to be marketed and used if they are not safe. Article 3 A safe medical devicc is one which complies with the Essential Requirements contained in Annex 1. Article 5 Devices complying with harmonized standards are deemed to comply with the Essential Requirements. Article I I Devices must go through a procedure (Annexes 2-7) to show that they conform to the Essential Requirements. The procedure depends on the Class of the device. Article 9 Devices are placed in Class I, IIa, IIb or I11 according to the rules given in Annex 9. Article I7 A device which complies with the Essential Requirements and has gone through the appropriate procedure must bear a C E mark. Article 4 Devices bearing a C E mark may circulate freely throughout the Community. Annex I-Essential Requirements There are six general requirements and 40 particular requirements. These are written in fairly general terms and for most of them standards are needed to provide the technical detail which designers and inspectors need. An outline of the Essential Requirements is given in figure 2.
1-6
0
0
Annexes 2-7-Con f o r m i Q assessment When the class of a medical device is known, the conformity assessment procedure which must be followed can be determined. The procedures, or components of the procedures, are described in detail in Annexes 2-7. Class I is the easiest, as that allows a manufacturer’s declaration. For all other classes there is intervention by a Notified Body. Class I11 is the most difficult because that requires pre-market approval of every single kind of device. The procedures for the four classes
Pcrf~irmancc Benefits must outweigh any side cffccts
Rules 1-4
6
used for storing body fluid connected to an active device in Class Ilat filtration of body fluids modification of body fluids some wound dressings
-
Biocnmpitihilily Drugldcvicc cumhinations
Stcriliiatiiin validatiiin Packaging
Nan-invasive devices Class I except:
-
-
Infcctiun and micrirhial ciintaminatiiin 0
0
An outline of the classification rules is given in figure 3 but, of course, to be certain about the classification of a device, Annex 9 must be studied in its entirety with great care.
Chemical and physicil priipcrtics 0
x
The classification scheme for non-active (non-powered) medical devices is based primarily on the sensitivity of the part of the body where the device is used. For active (powered) medical devices the classification scheme is based primarily on the emission of energy, or the delivery of substances, by the device.
Ccncral rcquircmcnls 0
7
Annex 9-ClassiJicalion rules It is necessary to provide some degree of proof that a device complies with Essential Requirements before a C E mark is applied. Because of the all-embracing nature of the MDD, there is no one conformity assessment procedure that is suitable for all products. Products are therefore divided into four classes according to the rules contained in Annex 9. A different conformity assessment procedure applies depending on the class into which the device falls.
5
Conncctiiins EMC susccptihility Firc and cxplosiiin
Transient use Most other applications 6 8
0 0
Rdusable surgical instruments Transient or short-term use (generally) Long-term use (generally) Contact with CCS or CNS
Accuracy and stahility Ldhclling Instructions fiir uhc
Prutcction against radiatiiin
9
Rcquircmcnts for mcdicdl dcviccs ciinncctcd o r equipped with an energy sourcc 0
0 0 0
13
S11ftwarc Alarms EMC cmissiiin Electric shock Contrul i i f delivery (if cncrgy or suhstanccs
Information supplicd hy the manufacturcr 0 0
Lahclling Instructitins for ubc
Figure 2. An oulline of the Essential Requirements for medical devices (Annex I of the MDD).
Class I Class Ila Class Ilb Class 111
Active therapeutic devices supplying energy or substances
-
not potentially dangerous potentially dangerous
Class IIa Class Ilb
10
Active diagnostic devices supplying energy or monitoring vital signs
Class Ila
II
Active devices not uivered hy Rules
-
tii
0
Class I Class Ila
Surgically invasive devices
Dcviccs with a mcasuring function
0
Class Ila Class IIb Class IIa + IIb
Devices invasive with respect to natural body orifices
Ciinstruction and cnvirirnmcntal properties 0 0 0
Class Ila Class IIa
9
I2 13
01
10
Class I
Devices incorporating a hiuavailahle drug
Class 111
Contraceptive devices
Class Ilh
Figure 3. An outline of the classijication rules for medical devices (Annex 9 of the MDD). 109
G. R. Higson Medical device regulations in the New Europe
The effects of the Medical Device Directive This Directive will, of course, bear primarily on manufacturers, but it will effect NHS users in several ways.
Hold tcchnical documentation
Hold technical documentation
EN 29002'Audit of sterilization/ measuring features
Verification by Notifid Body of sterilization/
J Med Eng Technol Downloaded from informahealthcare.com by Nyu Medical Center on 07/03/15 For personal use only.
Figure 4. Confonnig assessment proceduresfor Class I medical devices plus particular requirements.
E l Device
docMIentatmn Notified Body I
I
Figure 5. Confonnig assessment proceduresfor class IIa medical &rites plus particular requirements.
Notified Body EN 29002. Audit by Notified Body
EN 29003' Audit by N o t i f d Body
1-
-1
Product Verification by Notified Body
CEMark
Figure 6. Conformi& assessmentproceduresfor class IIb medical dcvices plus particular requirements.
I
Device
I
Hospitals inventing new devices or modifying existing devices are not manufacturers in the sense of this Directive as long as the devices are for their own use and are not sold to another user. The requirements of the Directive do not apply, therefore, but it would be foolish indeed for any NHS medical engineer not to satisfy himself that any device he has designed or modified complies with the Essential Requirements. The Product Liability Directive, implemented in the UK by the Consumer Protection Act 1987, would certainly regard him as a producer and, in the event of an incident, failure to comply with the Essential Requirements would make a defence very difficult. As soon as the Directive comes into effect (probably in July 1994) CE-marked products will begin to appear. Salesmen will no doubt be anxious to point out the superiority of their CE-marked product over a competitor which does not have the mark. This will not necessarily be correct. During the 3-year transition period it will be permissible to sell devices which comply with the national laws in force today-in the UK, no law at all. Products which are perfectly acceptable will continue to be sold without a CE mark. I t may be that the manufacturer has simply been slow to wake up to the existence of the Directive, he may be in a queue for the attention of a Notified Body, or the product may be one that will be withdrawn from the market before the end of the transition period.
At the end of the transition period (probably June 1997) only CE-marked products may remain on the market or may be used. What does it mean for a medical device to have a CE mark? It means that the device complies with the ERs-in most cases this will mean compliance with one or more harmonized standards. Harmonized standards are now being written in the European standards bodies CEN and CENELEC, or are being taken from international standards written in I S 0 or IEC.
by Notified Body I
V l
p G q
Figure 7. Conformi& assessment proceduresfor Class III medical devices plus particular requirements. are shown in figures 4-7. It will be seen that in every case the manufacturer has some choice in the procedure he wishes to follow. 110
The value of the C E mark will relate directly to the quality of the harmonized standards. Full participation by medical device users is essential if we are to have good standards. Both CEN and CENELEC have very active programmes to produce the standards needed by the Directive and more user input is desperately needed. Contact the BSI for more information. Some users, particularly medical users, are likely to find themselves involved in the assessment of products for CE marking. Manufacturers will be required to produce clinical evidence of the safety and performance of Class 111 devices, implants and possibly some other devices.
G.R. Higson Medical device rrgulations in
tlic New Europe
The Notified Bodies will have to call on the expertise of clinical users to help them evaluate this evidence.
J Med Eng Technol Downloaded from informahealthcare.com by Nyu Medical Center on 07/03/15 For personal use only.
Manufacturers will, of course, need to call on the expertise of users to help gather such evidence. Many readers will bc accustomed to carrying out clinical trials on new devices either on behalf of manufacturers or on devices of thcir own invention. Take note that the conduct of clinical trials will be rigidly controllcd in future. The Directive stipulates that clinical investigations must be carried out in accordance with the provisions of Annex 10. I n practice this will mean in accordance with the forthcoming European standard EN540 which is currently with national standards bodies for comment. Furthermore, if the device is in Class 111 or is an implant in Class IIa or Class IIb, the trial cannot be carried out without notifying thc Department of Health. Full details of the trial must be submitted to the Department and the trial may be commenced only if there is no reaction from the Department after a consideration period currently standing at 45 days. These drastic changes from current practice must be understood by all those involved in thc development of new medical devices or the conduct of clinical trials. Another new feature of this Directive which will make demands on NHS users is the requirement for postmarket surveillance and incident reporting. Manufacturers of all Class I1 and Class 111 devices are required to give an undertaking, during thc conformity assessment procedure, that they will notify the national authorities of thc following: Any deterioriation in the characteristics and/or performancc of the dcvicc, as well as any inaccuracies in the instruction leaflet, which might lead to or might have led to the death of a patient or user or to a serious deterioration in their state of health.
(2) Any technical or medical reason connected with the device leading to recall of devices of the same type by the manufacturer. In addition, manufacturers of Class I I b and Class I11 devices are required to set up a post-market surveillance system. Detailed guidance on the operation of the reporting and post-market surveillance systems is now being prepared by the Commission. What is already clear is that manufacturers will be unable to discharge these obligations without cooperation from NHS users. This Directive is now under discussion in the European Parliament, the Economic and Social Committee and an expert Working Group set up by the Council of Ministers (which will have to vote this Directive into law). Public discussion of the sweeping changes which it will introduce has been extremely limited, and participation by the professions all but non-existent. Even at this late stage it is not too late for professional views to be expressed to the Medical Devices Directorate of the Department of Health. However, it may be more realistic to urge more active participation by professional users of medical devices in the drafting of the law that will bring this Directive into effect in the UK, in publicizing the Directive and its consequenccs and, most importantly of all, in the preparation of the standards with which medical devices will have to comply.
References I . Cecchini, P (1988) The European Challenge 1992 (Wildwood House, Gower House, Aldershot, UK). 2. Commission of the European Communities (1985) White Paper on Completing the Single Internal Market by 1992. 3. Council Resolution 85/C 136/01 (1985) EC Ofjcial Journal C 136. 4. Council Directive 90/385 (1990) EC OficialJournal L189. 5. COM(91) 287 (1991) EC Ofjcial Journal C237.
111
