26. 6. 89 Official Journal of the European Communities No C 159/47 
Opinion on the proposal for a Council Directive on the approximation of the laws of the 
Member States relating to active implantable electromedical equipment (*) 
(89/C 159/17) 
On 16 January 1989, the Council decided to consult the Economic and Social Committee, 
under Article 100 A of the Treaty establishing the European Economic Community, on the 
abovementioned proposal. 
The Committee instructed the Section for Protection of the Environment, Public Health and 
Consumer Affairs to prepare its work on the matter. In the course of this work, the Committee 
appointed Mr Proumens as rapporteur-general. 
At its 265th plenary session (meeting of 26 April 1989) the Economic and Social Committee 
adopted the following Opinion by a unanimous vote. 
1. General comments 
1.1. The Committee is in agreement with the present 
proposal. However, certain specific comments and res­
ervations are expressed below, although these do not 
basically call into question the proposal. In addition, it 
should be borne in mind that this proposal does not 
cover non-active devices or prostheses, which will be 
the subject of another proposal for a Directive. 
1.2. The proposed Directive has two clear-cut aims: 
a) to harmonize conformity assessment procedures 
and to encourage harmonization of technical stan­
dards; 
b) to guarantee the safety of the active implantable 
electromedical equipment covered by the proposed 
Directive. 
1.3. The equipment concerned is not confined solely 
to cardiac stimulators, though these are most familiar, 
but also encompasses other types of devices used for 
the following purposes: 
— defibrillation, 
— biostimulation, 
— input of an active substance (for example, medi­
cines), 
— active implantable organs, 
— implantable artificial heart, 
— implantable monitoring devices. 
1.4. The use of all such equipment is currently 
increasing significantly. This is due both to new tech­
nologies and the increasing longevity of the population 
in the Member States. 
1.5. According to industry estimates, market turn­
over in such equipment is currently running at around 
400 million ECU. We do not have any accurate statistics 
on quantity, but fairly reliable estimates from the same 
(•) OJ No C 14, 18. 1. 1989, p. 4. sources suggest that some 200 000 pacemakers are used 
annually, i.e. more than 500 per day throughout the 
Member States. 
1.6. Apart from the commercial considerations, these 
devices are clearly intended to give often many more 
years of life (as in the case of pacemakers). They also 
alleviate discomfort (e.g. 'drug pumps' implanted in 
patients suffering from diabetes or very painful diseases 
such as cancer). In addition, muscle stimulators are 
increasingly used in the case of patients with partial 
paralysis. 
1.7. Some devices, particularly pacemakers, could be 
reused on other patients. Although such cases are fairly 
rare, it is obvious that where this occurs the devices 
must be retested, especially from the point of view of 
sterility, effectiveness and compatibility. 
2. Technical harmonization and safety requirements 
for such equipment 
2.1. The present proposal can be split into four main 
headings: 
a) harmonization; 
b) safety; 
c) conformity assessment; and 
d) limits and constraints. 
2.2. For harmonization purposes, the proposed 
directive has taken account of the laws existing in a 
number of Member States and the assessment processes 
as defined must ensure free movement of such equip­
ment without compromising the level of safety required 
and existing in those Member States which have already 
passed legislation. 
No C 159/48 Official Journal of the European Communities 26. 6. 89 
2.3. The essential safety criteria are: 
— product sterility, 
— technical safety, and 
— clinical evaluation. 
2.4. At present, a number of standards have been 
devised by the European Committee for Electrotechni-
cal Standardization (Cenelec), particularly for pace­
makers, and these could be extended fairly easily to 
other types of equipment. 
In addition, the system of good manufacturing practice 
(GMP) codes enables firms to ensure that the criteria 
mentioned above are respected. 
2.5. As regards conformity assessment, the pro­
visions in the present proposal are based on existing 
rules, but allow some flexibility in implementation. 
2.6. At present the pace of technical progress in 
all such devices is extremely rapid: a device will be 
modified—sometimes even radically transformed— 
every 3 to 4 years. 
2.7. Moreover, in view of the diversity of the equip­
ment concerned and the extent of technological change, 
rules must be high level but the way they are applied 
must be flexible. 
2.8. Industry is well aware that it must accept strin­
gent standards, and notably the attendant costs; but 
producers feel that the procedures set out make it 
possible to guarantee that the equipment meets all 
the requisite quality requirements without impeding 
distribution by setting over-specific standards which 
would take so long to frame that they would be a 
significant obstacle to the development of new equip­
ment. Delays in marketing these devices caused by too 
much red tape would ultimately harm the patient, quite 
apart from the difficulties of all kinds which would be 
faced by firms developing new products. 
3. Benefits of harmonization 
3.1. After sounding out the groups concerned (medi­
cal specialists and representatives of the industries 
involved), the Commission has come to the conclusion 
that in addition to bringing about free movement of the 
equipment concerned, harmonization should achieve 
savings of 4%. Bearing in mind the size of the market 
this figure represents savings of 16 million ECU per 
annum for the Community as a whole, which is a far 
from negligible sum. 
3.2. It must also be remembered that although such 
devices, particularly pacemakers, are relatively expens­ive (between 1 300 ECU and 4 000 ECU), medical 
insurance schemes normally refund the full cost. The 
savings achieved can only be beneficial to those operat­
ing such schemes. 
4. Specific comments 
4.1. Definition of a medical device [Article 1 (2)] 
In this definition, two terms should be either modified 
or expanded, namely: 
— 'substance', and 
— 'in combination'. 
The term 'substance' may cause confusion and, conse­
quently, lead to the devices in question being treated 
as medicines, with all the implications that this would 
entail from the point of view of distribution and the 
associated advertising. 
In addition, the term 'in combination' should be 
developed to explain that what is meant is the device 
itself and peripherals such as electrodes etc. 
4.2. Prototypes 
Prototypes intended for research and/or testing are 
mostly sold to medical research units; this does not 
mean that they are already being marketed on a more 
general scale. 
4.3. The question arises as to whether a third indent 
should not be added to Article 4 (2), namely: 'Devices 
manufactured on prescription.' 
However, this understandable request should not, if it 
is accepted, become a means of avoiding all of the 
procedures. It should only apply to isolated cases justi­
fied by special circumstances. 
4.4. Mention of the CE-mark—Article 10 (1) 
This mark may only be affixed on the packaging or on 
the documents accompanying the device. This is 
because some devices are very small and it may not be 
possible to affix the CE-mark on the device itself (which 
is sometimes no more than an electric wire). 
4.5. Penalties—Article 11 
The Committee did think that the penalty for wrongful 
affixing of the CE-mark seemed fairly lenient. 
26. 6. 89 Official Journal of the European Communities No C 159/49 
This is not at all the case, because the withdrawal of a 
certificate of approval is, on the contrary, a very heavy 
penalty for the firm involved, for its reputation would 
be severely damaged, since those who order such devices 
are specialists, i.e. doctors, and they would know 
straightaway which firms were breaking the rules. 
On the other hand, perhaps the Commission should 
consider recommending to the Member States that they 
make provision for penalties in their respective national 
laws. 
5. Special remarks 
5.1. The Committee stresses that all the proposed 
provisions should be applied both to devices manufac­
tured in the European Community and to devices from 
non-EEC countries. 
5.2. The Committee has taken note that Annexes 1 
to 5, particularly Annexes 1 and 5, can only be amended 
through a proposal for a Council directive, which means 
that the normal procedure of consulting the European 
Parliament and the Economic and Social Committee 
must be followed. 
Done at Brussels, 26 April 1989. 5.3. The Committee recommends that the Com­
mission could perhaps review some of the headings in 
Annex 1 and perhaps modify the text of Annex 5 on 
clinical evaluation, so that the provisions regarding 
safety are in keeping with the proposal on this matter 
made by the European working group on cardiac 
pacing. 
5.4. The Committee recommends that the Com­
mission incorporate in Appendix 2 (and in point 2.7 in 
particular) provisions which enable a firm to appeal 
against the withdrawal of, or the refusal to issue, an EC 
type-approval certificate. Detailed rules for the appeals 
procedure should be laid down. 
5.5. The Committee believes that a time limit should 
be set for the issue of a certificate. 
5.6. The Committee also believes that the rules 
covering confidentiality (set out in point 7 of 
Appendix 4) should be spelt out in detail, as is the case 
for pharmaceutical products. 
The Chairman 
of the Economic and Social Committee 
Alberto MASPRONE