Memorandum by the Medical Devices Agency
Table 1: Chronology of Key Events
Response to Scientific and Clinical Questions
Guidance to Healthcare Professionals
Table 2: Summary of Information given to Healthcare
Provision of Information to the Public
Direct Communication with the Public
Regulatory Initiatives by MDA
Appendix 1: IRG Conclusions and Recommendations
1. The first priority of the Medical Devices
Agency (MDA) is to protect public health and safeguard the interests
of patients by ensuring the safety of medical devices. MDA has
responded comprehensively to concerns over the safety of breast
from 1988, assessing the risk of
cancer arising from silicone gel breast implants. The risk was
considered remote and these implants remain available;
from 1991, assessing the risk of
cancer arising from the breakdown of the polyurethane coating
applied to some implants. MDA issued two Advisory Notices informing
clinicians that these implants should not be used;
from 1991, assessing evidence for
a link between silicone gel breast implants and autoimmune disease
or other associated health problems. These issues were addressed
in a series of major scientific reviews, two by MDA and an Independent
Expert Advisory Group, in 1992 and 1994, and a third by an Independent
Review Group (IRG). The IRG concluded, in 1998, that risks from
silicone gel breast implants are no greater than for any other
type of implant;
from 1998, assessing the safety of
lipid-filed breast implants. These implants were withdrawn from
use in the UK in 1999 and MDA gave advice in 2000 that women should
consider having them removed;
from 1999, assessing the safety of
two types of hydrogel-filled breast implants. These implants were
withdrawn from use in the UK in 2000.
2. The provision of reliable information
to clinicians and via them to patients is the key element of MDA's
risk communication strategy. MDA maintains close contact with
relevant specialists and professional bodies to ensure that the
advice it gives is appropriate and that both clinicians and their
patients are fully informed. In addition to the reports mentioned
above, which were widely distributed, relevant information has
been communicated through:
6 MDA Advisory Notices distributed
to the Health Service;
2 letters to all doctors from the
Chief Medical Officer (CMO);
4 articles in CMO's Update, sent
to all doctors.
3. The provision of reliable information
to patients has been achieved by:
appending information for women to
4 of MDA's Advisory Notices;
publication of an information booklet
for women considering breast implants. This was in response to
the IRG's concern that some women had been poorly informed about
the potential risks associated with breast implant surgery;
updates on the Internet, press releases
and help-lines, when appropriate;
direct responses by MDA or Ministers
to the many hundreds of letters from patients, their advocacy
groups and MPs.
4. MDA has called for and secured a review
of the operation of the European Medical Devices Directives, which
should lead to more stringent pre-market assessment procedures
for breast implants and improved performance of assessment bodies.
MDA has assisted the European Commission in specifying particular
requirements applicable to the assessment of regulatory conformity
for breast implants.
5. Silicone gel breast implants were first
introduced in around 1962, when there were no specific statutory
regulations in place to control the marketing and use of medical
devices, either in the USA or Europe. Since then, the use of breast
implants has increased gradually and it is now estimated that
over 10,000 women receive breast implants each year in the UK,
80 per cent of those opting for silicone gel.
6. Several concerns have been voiced by
clinicians and patients, over the last 10 years or so, related
to the safety of breast implants. The MDA has responded to these
by evaluating the potential long-term side effects associated
with breast implants. The concerns have included the possibility
of cancer, the incidence of local complications and the nature
of the advice given to people considering surgery. The potential
hazard that has given risen to the greatest concern has been the
possibility of connective tissue (or autoimmune) disease.
7. The MDA has been responding to concerns
raised about breast implants since 1988, when it examined data,
highlighted by an American consumer interest group, showing that
silicone gel-filled implants caused cancer in rats. The Government
expert Committee on Carcinogenicity considered this risk to be
8. In 1991, the MDA started to look into
the risk of cancer arising from the breakdown of the polyurethane
coating applied to some implants and into the growing concern
that silicone gel breast implants could cause autoimmune effects.
This latter issue has been a substantial part of the MDA's work
ever since, involving staff in writing two major scientific reviews
and assisting an Independent Review Group with a third, as well
as responding directly to the public.
9. Between 1998 and 2000, MDA responded
to concerns raised by plastic surgeons by reviewing safety data
relating to lipid- and hydrogel-filled breast implants. Lipid-filled
implants were withdrawn from use in UK hospitals in 1999 and,
in 2000, women were advised to consider having them removed. Also
in 2000, two types of hydrogel-filled breast implant were withdrawn
from use in the UK. As a result of the MDA's investigations, the
only breast implants currently available in the UK are filled
with silicone gel or saline.
10. A brief chronology of MDA's response
to key events is presented in Table 1.
CHRONOLOGY OF KEY EVENTS
|MDA reviews carcinogenicity data on silicone gel and refers it to DH Committee on Carcinogenicity (COC), who conclude that the risk to humans is remote.
|1991||MDA reviews carcinogenicity of polyurethane coating applied to some breast implants and refers paper to COC, who conclude that risk is theoretical but low. MDA advisory notices issued in 1994 and 1996.|
Concern in medical literature about possible link between silicone gel breast implants and autoimmune disease. An Advisory Panel to the US Food and Drug Agency (FDA) recommend continued availability of silicone gel breast implants while safety and efficacy data are collected.
MDA commences review of relevant published literature and manufacturer's data.
|1992||FDA imposes a US moratorium on silicone gel breast implants. FDA Advisory Panel notes that new data are inconclusive, but FDA restricts implantation to clinical trials for defined categories of patient. CMO Letter issued to all UK doctors to explain situation.|
MDA reviews scientific data on hypothesised link between silicone gel breast implants and autoimmune disease and refers report to specially convened Independent Expert Advisory Group (IEAG). IEAG conclude that there is no evidence to indicate a change in practice or policy, but recommends a registry to assist collection of relevant data.
|1993||National Breast Implant Registry set up by MDA in response to IEAG recommendation.|
MDA report published; IEAG conclusions reported in CMO Letter and CMO's Update.
|1994||Escalating US legal claims culminate in proposal of $4.75B class action, leading to an increased level of public interest and concern over breast implant safety.|
MDA reviews scientific data published since 1992 review. IEAG confirms lack of evidence of link with autoimmune disease. Report sent to all UK plastic surgeons; around 10,000 copies distributed worldwide. Conclusions reported in CMO's Update.
MDA issued a Safety Advice Bulletin on polyurethane-coated breast implants.
|1996||Manufacturer Dow Corning makes provision for bankruptcy; public concern heightens.|
MDA issued a second Safety Notice on polyurethane-coated breast implants.
|1997||Incoming Minister responds to concern among implanted women by ordering the Independent Review Group (IRG) to be set up.|
IRG collects and considers evidence, including that provided by implanted women.
|1998||IRG report concludes that silicone gel breast implants are safe but recommends controls on medical practice and better information for patients. IRG report sent to all UK plastic surgeons; findings reported in CMO's update. Website with report and additional information set up.|
MDA co-ordinates implementation of IRG recommendations.
Plastic surgeons report concern over swelling around lipid-filled breast implants. MDA calls for and reviews manufacturer's technical data.
|1999||MDA's review of lipid-filled breast implants reveals serious concerns over long-term safety. MDA's conclusions confirmed by members of Committee on Toxicology (COT). Product withdrawn; MDA issues Advice Notice.
|2000||Department of Health booklet on Information for Women considering breast implant surgery published.|
MDA sets up expert advisory group to review new data on breakdown of lipid filling. Group recommends removal of implants. MDA issues Hazard Notice.
As part of ongoing review of biological safety of all breast implants, MDA calls for and reviews manufacturers' safety data for two hydrogel-filled breast implants and concludes that there are serious concerns over long-term safety data. MDA's concerns confirmed by COT. Products withdrawn; MDA issues two Device Alerts.
11. Several safety reviews has been carried out by MDA
scientific staff and/or independent expert groups. These have
led variously to reassurance about safety or precautionary action.
Information about these outcomes has been passed on to relevant
clinicians and the wider public through a variety of routes.
Expert Advisory Groups
12. The MDA has approached two of the Government's standing
committees for advice
on the cancer risks arising from silicone gel and polyurethane-coated
breast implants, and the toxicological risks arising from lipid-
and hydrogel-filled breast implants.
13. Two ad hoc groups were set up to advise the Department
of Health on conclusions about risks and recommendations about
clinical practice. The Independent Expert Advisory Group (IEAG)
advised the Department of Health from 1992 until 1997 on the suspected
link between silicone gel breast implants and autoimmune disease.
A further group was set up to advise the MDA in 2000 about risks
arising from the breakdown of the lipid filler present in some
The Independent Review Group
14. In June 1997, the Chief Medical Officer set up an
Independent Review Group (IRG). This was in response to concern
by the Minister for Health, Baroness Jay, that women continued
to complain of severe medical problems which they attributed to
their implants and that many patients appeared to have been inadequately
counselled prior to breast implantation.
15. The IRG's remit was to review the evidence relating
to the possible health risks associated with silicone gel breast
implants, to examine the issues relating to pre-operative patient
information and to report on its conclusions.
16. The IRG published its findings in July 1998,
confirming the lack of association between silicone implants and
disease but highlighting problems relating to information given
to patients prior to surgery. The IRG made several recommendations
on how their concerns should be addressed. (Appendix 1 lists the
IRG's conclusions and progress on its recommendations.)
17. The IRG continues to meet and review new evidence.
In October 2000 they held an Open Day to give members of the public
and other interested parties an opportunity to submit new evidence
and put questions to the Group.
The National Breast Implant Registry
18. The National Breast Implant Registry (NBIR) was set
up in 1993 in response to a recommendation by the IEAG. The aim
of the NBIR is to provide a comprehensive record of breast implant
operations carried out in both the private and the NHS sectors
in the UK. The MDA funds the NBIR and acts as secretariat of the
NBIR Steering Group, which was set up in 1999 to advise the MDA
on the management of the Registry and the use of the data. A pilot
study using NBIR data, designed in the light of the IRG's recommendations,
has been commissioned.
19. The MDA processes around 7,000 reports of suspected
problems by medical device users each year, and establishes whether
these are isolated events or if there is a wider problem. Where
significant risks to public health are identified, either from
the investigation of an individual incident or from periodic trend
analyses, the MDA ensures that appropriate remedial action is
taken to minimise those risks. This may include a product recall
or the issue of an Advisory Notice to the Health Service.
20. The MDA has investigated a total of 265 reports involving
breast implants (including breast implants filled with silicone
gel, saline, soya bean oil and hydrogels). With respect to silicone
gel, polyurethane-coated and hydrogel-filled breast implants,
neither the assessment of individual reports nor trend analyses
revealed any unexpected problems. However, reports of breast swelling
led ultimately to the advice that soya bean oil-filled implants
should be removed.
21. In response to the recommendation of the IRG that
all clinicians should report breast implant adverse effects to
the MDA, specific
guidance on the reporting of adverse incidents with breast implants
was published in August 1999 and circulated to all plastic surgeons
in the UK.
22. With regard to dealing with professionals and offering
guidance, the MDA's policy on matters relating to breast implantation
has been two-fold, namely:
to provide all relevant clinicians with full information
about the MDA's investigations, the actions taken and the background
to those actions, so that they can keep both themselves and their
patients fully informed;
to discuss emerging issues with representatives
of all the relevant professional bodies and clinical specialists,
prior to any information being sent out to the Health Service.
This ensures that such information is in a format which is helpful
in terms of setting out the proposed action points and the background
to those action points. It also ensures that the documentation
contains helpful, detailed information, so that patients' questions
can be sensibly addressed.
The overall aim is to ensure close liaison between the MDA
and clinicians in terms of working towards the best interests
of the public.
23. MDA maintains close contact with relevant professional
bodies to ensure
that appropriate advice and information is communicated to clinicians.
24. Table 2 summarises the measures taken by MDA to inform
healthcare professionals of issues relating to breast implants.
SUMMARY OF INFORMATION GIVEN TO HEALTHCARE PROFESSIONALS
|Date||Information disseminated to the Health Service
|Jan 1992||CMO letter to all doctors in England/regional directors of public health/district directors of public health (similar letters sent out by the Chief Medical Officers of Scotland, Wales and Northern Ireland) on the possible health risks associated with silicone gel breast implants.|
Copies of CMO letter circulated to individual members of relevant professional bodies: British Association of Plastic Surgeons (BAPS), British Association of Aesthetic Plastic Surgeons (BAAPS), British Association of Cosmetic Surgeons (BACS), following discussion with the Presidents of these bodies.
|Mar 1993||Second CMO letter to all doctors in England:|
laying out the conclusions from the Independent Expert Advisory Group;
laying out advice from the Advisory Committee on Breast Cancer Screening (ACBCS) and the Royal College of Radiologists Breast Group (RCRBG);
setting out details of the National Breast Implant Registry.
A copy of the letter and the report from the Expert Advisory Group individually circulated to all members of the professional bodies following discussion with the Presidents of those bodies.
Article in CMO Update circulated to all doctors, setting out information about the setting up of the National Breast Implant Registry and how to register.
|May 1994||US District Court in Birmingham, Alabama, announced the commencement of an international outreach programme to advise women and their family members of a proposed Class Settlement. The US Court employed the services of a London based PR agency to disseminate the information in the UK and this agency discharged its obligation by sending a letter to a number of Ministers, DoH officials, Health Service managers and professional bodies. Because of the increasing anxiety of implanted patients, resulting from ill-informed press coverage of the Court action, and because it was felt that the majority of patients might never hear about the Class Action, MDA proposed that the most appropriate course of action would be the issue of a suitably worded Press Notice. This was agreed by Ministers.|
MDA held meetings with the professional bodies, requesting their help in promulgating the conditions of the settlement to all relevant patients.
|June 1994||Article in CMO Update circulated to all doctors setting out the results of the Expert Analysis requested by MDA in respect of a paper claiming oesophageal abnormalities in children of Breast implanted women.
|Sept 1994||Safety Action Bulletin issued by MDA in respect of further evidence from the Committee on Carcinogenicity on polyurethane coated breast implants with potential release of a possible carcinogenic degradation product following breakdown of polyurethane foam, to relevant health care professionals.|
A copy of this Notice was circulated to all members of the relevant professional bodies following discussion with the Presidents of those bodies, with a covering letter.
|Dec 1994||The results of the MDA publication of updated analysis of all medical and scientific literature relating to silicone breast implants and connective tissue disease communicated with the professional bodies. Copies of the documents individually circulated to all members of these bodies.
|Jan 1995||Article in CMO Update circulated to all doctors providing results of updated analysis.|
American courts announced registration for Class Action was extended until March 1995. Proposal for a further Press notice was agreed by Ministers.
Further discussions held with Presidents of relevant professional bodies to ensure the promulgation of this information as widely as possible to all relevant patients.
|Apr 1995||Letter from CMO to opposite numbers in European Union sending out a copy of updated analysis for distribution to health care professionals
|Sept 1996||Following discussions with Presidents of relevant professional bodies, letter sent out to all members of professional bodies, drawing to their attention a press advertisement concerning bankruptcy of the breast implant manufacturer Dow Corning and preservation of the right to pursue existing or future claims undeer the US legal system.
|1997||Dr Ludgate (MDA's Medical Director) asked to sit on the Council of BAPS in order to regularly report any updates regarding silicone breast implants, so that this information could be promulgated to all members of the professional bodies via their newsletters. Dr Ludgate has attended these meetings regularly since this time.
|July 1998||Final report from the Independent Review Group. A copy of the final report with a covering letter sent to all members of the relevant professional bodies individually, including members of the British Association of Surgical Oncologists (BASO), following discussion and agreement with the Presidents.
|Aug 1998||Article in CMO Update circulated to all doctors setting out the outcomes and recommendations from the Independent Review Group Report.
|Oct/Nov 1998||Meeting with Presidents of relevant professional bodies to discuss the conclusions and recommendations from the Independent Review Group report and engage their help and explain their role in implementing the relevant recommendations.|
With respect to IRG Recommendation 7 (that all clinicians should report breast implant related adverse incidents to the MDA Adverse Incidence Centre. The MDA should provide guidance to clinicians on which incidents should be reported), a specially prepared guidance document accompanied by a covering letter, sent individually to all members of relevant professional bodies.
At MDA's request, the Presidents of relevant professional bodies asked their members to report all adverse events encountered with Trilucent breast implants to MDA.
|Mar 1999||Medical Device Advice Notice issued re Trilucent Breast Implants. Contents agreed after prior discussion with the Presidents and office holders of relevant professional bodies. Individual copies of the Advice Notice sent to all members of the relevant professional bodies with a covering letter.
|Nov 1999||Meeting with Mr Michael Brough, Chairman of the Royal College of Surgeons Committee set up to produce Best Practice Guidelines on breast implantation to input to these Guidelines, particularly with regard to inputting information on which adverse incident to be reported and how to report adverse incidents.
|June 2000||Hazard Notice re Trilucent breast implants sent to all members of the relevant professional bodies, following a number of discussions with scientists and Presidents of relevant professional bodies and representatives of the independent and private sectors, as to the advice to be given and the strategy for implementation of this advice.
|Oct 2000||With respect to IRG Recommendation 1 (that all patients undergoing cosmetic breast augmentation surgery should be able to obtain information about the benefits and risks of such surgery), Department of Health booklet on Information for Women produced. Numbers of copies sent individually to all members of relevant professional bodies.
|July 2000||Letter sent to all members of relevant professional bodies providing further information on a number of issues in relation to Trilucent Breast Implants, in order to help in the future management of implanted women and in answering a number of queries raised both by implanting surgeons and their patients. This information also provided to the manufacturer for them to give out as appropriate, provided to NHS Direct, placed on the web site and promulgated by the National Breast Implant Registry to all implanting centres registered, including those in the independent and private health care sectors.
|Nov 2000||Invited lectures given by MDA to the Annual Meeting of the BAPS setting out the facts and updating information on Trilucent breast implants.
|Nov/Dec 2000||Discussions with the Presidents of all the relevant professional bodies and with representatives of private and independent health care sectors re hydrogel breast implants. Obtained their agreement to proposed strategy and wording of the Device Alert for handling withdrawal of these implants from the market. Individual copies of Notice sent to all members of professional bodies with attached information with respect to answering patients' questions. This information also on the Internet.
|Dec 2000/Jan 2001||Discussions held with Councils of all relevant professional bodies with regard to their agreement to a universal consent form, so as to facilitate future research projects into any associated short- and long-term health risks with breast implants. Agreement reached. Consent form to be circulated to all individual members of relevant professional bodies with an entry in the relevant Newsletters.
25. MDA interacts predominantly with the Health Service
and manufacturers. However, in line with the general trend towards
greater public access to Government departments, MDA has dealt
increasingly with members of the public over the last six years.
The provision of reliable information to the public, through the
media and other relevant routes, now forms a key part of communications
strategies developed by the Department of Health in response to
identified risks. MDA's website contains information on breast
implants and links to MDA's recent Advisory Notices and the IRG
26. In 1996, the NHS Breast Screening Programme published
a short leaflet for women who have breast implants.
27. The IRG report, published in 1998, is a source of
information both for professionals and for women considering breast
implantation or concerned about their breast implants. In this
respect it differs from the previous expert reports published
by the MDA, which were primarily intended to inform the medical
and scientific community. Women can obtain a free copy of the
IRG report. 56
28. The IRG recommended that all patients undergoing
cosmetic breast augmentation surgery should have access to information
on the risks of surgery (see Appendix 1). In response to this,
the Department of Health set up a drafting group, on which patient
advocacy groups were represented. The resulting booklet, published
in October 2000, is attached. 57
29. The four MDA Advisory Notices issued in 1999-2000
relating to soyabean oil- and hydrogel-filled breast implants
included annexes which provide information that is intended to
be passed on, during a clinical consultation, to women who have
these types of breast implants. This information is also available
via the MDA's website.
30. At the same time that these Notices were issued,
the Department of Health arranged for appropriate information
to be available to the press and through existing help lines (such
as NHS Direct). Manufacturers also made arrangements for the same
information to be available, for example, through help lines.
31. In November 2000, the IRG held an Open Day to allow
interested parties to present new evidence and put questions to
members of the Group.
32. In around 1995, the MDA started to receive correspondence
from members of the public regarding breast implants. Since then,
theMDA has dealt with hundreds of letters and telephone calls
from members of the public concerned about breast implants, with
over 350 items of correspondence with one individual alone. The
majority of concerns raised related to the biological safety of
silicone gel breast implants.
33. Some of the women who contacted the MDA in the mid
1990's expressed concern that their silicone implants might be
the cause of their ill health. The MDA's technical and clinical
staff offered them reassurance that, in spite of considerable
research, no causative link between implantation and disease could
34. Several women disputed the consensus that there was
no scientific evidence supporting a link between silicone gel
breast implants and connective tissue disease and called for a
ban. They felt that their belief that their disease was the result
exposure to silicone implants was not taken seriously by MDA or
the medical profession and that, as a result, they were denied
proper treatment by the Health Service.
35. In around 1996, a few women organised various advocacy
groups to campaign for the banning of silicone gel breast implants
and/or the provision of better information to patients.
Parliamentary Ombudsman's investigations
36. The way MDA dealt with some of the letters received
in around 1996 was the subject of a series of six investigations
by the Parliamentary Ombudsman in 1998-99. The complainants asserted
that, in addition to noting the information provided and responding
to the concerns expressed, MDA should have logged their letters
as adverse incident reports. In response to the wishes of these
correspondents, from 1997, MDA logged all such letters as adverse
incident reports, irrespective of whether a device performance
problem was indicated.
37. The Ombudsman found that, in two cases, MDA had failed
to respond effectively to the letters and, in five cases, MDA
had been remiss in failing to keep some letters on file. However,
in no case did he find sufficient grounds to criticise MDA for
not taking the letters as a basis for action through the adverse
incident procedure. 60
A further complaint to the Parliamentary Ombudsman, relating to
the failure of MDA to disclose the identity of experts who had
provided them with informal advice, was upheld. 
38. Breast implants are classed as medical devices and
regulated by the European Medical Devices Directive (MDD). 
This is a "new approach directive" which imposes a light
touch to regulation and harmonises safety and performance requirements
for medical devices throughout the EEA, thus ensuring a single
Operation of the Medical Devices Directive
39. The United Kingdom currently has some concerns over
the operation of the MDD and, in July 2000, called for and secured
a review of its operation by the European Commission. One of the
main changes MDA is pursuing is the re-classification of all implants
from an intermediate to the highest risk category. This will tighten
the regulatory controls and the pre-market requirements for such
products across Europe. The European Commission has already accepted
that breast implants should be reclassified as high-risk devices
and is currently preparing measures to achieve this.
40. MDA has also been concerned about the uneven performance
of Notified Bodies across Europe. Notified Bodies are independent
certification organisations, responsible for ensuring that a manufacturer's
processes or products meet the requirements of the MDD. To improve
the overall level of performance of Notified Bodies, MDA strongly
promoted the establishment of The Notified Body Oversight Group
(NBOG), whose first meeting took place in November 2000.
41. The two key issues being tackled by NBOG are transparency
in the way each Member State carries out the designation and monitoring
activities for Notified Bodies and the competence of both Member
State and Notified Body assessors.
Petitions to the European Parliament
42. In March 1999, two petitions to the European Parliament,
calling for an immediate ban on silicone gel breast implants,
were tabled by MEPs on behalf of women who believe that breast
implants have caused adverse effects. The Petitions Committee
of the European Parliament commissioned a Scientific Technological
Options Assessment to enable more informed legislative and policy
decisions to be made.
43. The European Parliament assessment recommended that
"critical specific measures be adopted and implemented to
improve information for patients, tracking and surveillance, quality
control and assurance and key research". The findings of
this assessment were similar to those of the IRG and most of its
recommendations have already been implemented in the UK (See Appendix
44. The European Parliament Petitions Committee asked
the European Commission to develop proposals along the recommended
lines and the Commission adapted an existing draft document, that
specified regulatory expectations for breast implants. MDA has
assisted the European Commission in the development and adaptation
of this document since 1995.
45. The Petitions Committee is due to meet on 21 March
2001, to consider a final response to the petitions laid before
them and the Commission document.
The Committees on Toxicity (COT) and Carcinogenicity (COC) of
Chemicals in Food, Consumer Products and the Environment. Back
See Appendix 1, Recommendation 7. Back
Medical Devices Agency; Guidance on the medical devices vigilance
system for CE-marked breast implants; MDA, August 1999. (http://www.medical-devices.gov.uk/reg-guid.htmViligance) Back
The most relevant bodies are The British Association of Plastic
Surgeons (BAPS), The British Association of Aesthetic Plastic
Surgeons (BAAPs) and The British Association of Cosmetic Surgeons. Back
The IRG report can be ordered on 020 7972 8077 or downloaded:
Department of Health; Breast Implants: Information for women
considering breast implants; October 2000. Available from the
Health Information Service, NHS Direct and the Internet: http://www.doh.gov.uk/bimplants Back
255/99, 338/99, 366/99, 391/99, 410/99 and 1100/99). Back
Council Directive 93/42/EEC of 14 June 1993 concerning medical
devices. Official Journal of the European Communities; L 169;
1-43 (12 July, 1993). Back