Explanatory Memorandum to COM(2005)681 - Amendment of Council Directives 90/385/EEC and 93/42/EEC and Directive 98/8/EC as regards the review of the medical device directives - Main contents
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| dossier | COM(2005)681 - Amendment of Council Directives 90/385/EEC and 93/42/EEC and Directive 98/8/EC as regards the review of the medical device ... |
|---|---|
| source | COM(2005)681  |
| date | 22-12-2005 |
- 110Grounds for and objectives of the proposal
Since its adoption in 1993, a great deal of experience has been gained on the implementation of the Directive 93/42/EEC concerning medical devices. Whilst overall the experience has been extremely positive, some experience reveals that the Directive requires improved implementation by all parties concerned. Furthermore, to support this improved implementation, legislative modification is necessary both to clarify certain existing requirements and to provide a legal basis for planned initiatives. The proposal amends Directive 93/42/EEC in this regard and also, in order to align the text of the framework Directives on medical devices, it amends Directive 90/385/EEC relating to active implantable medical devices.
- 120General context
Directive 93/42/EEC itself requests the Commission to submit a report to the Council, no later than five years from the date of implementation of the Directive, concerning certain aspects of the functioning of the Directive. It was the view of various Member States that the review called for under Article 11 i should be extended to cover not only those aspects referred to in the Article, but also to cover all elements of the Directive that have given rise to concern or where improvements can be made.
Arising from this review process, a Report on the functioning of the Medical Devices Directives was published in June of 2002. The conclusions of this Report were brought forward by the Commission in its Communication COM (2003)386 which was welcomed by the Council in its Conclusions of December 2003 and was received favourably at Parliament.
The Communication highlighted that whilst the Devices Directives provide in themselves an appropriate legal framework, there is room for improvement. The most important areas where improvement should be made concern:
conformity assessment - where questions arose as to the absence of clear rules on design examination by notified bodies,
the sufficiency and adequacy of clinical data for all classes of devices,
post market surveillance - where better coordination of activities in the area of post market surveillance are needed,
Notified Bodies - in relation to their competence for the tasks for which they are designated, differences in interpretation between Notified Bodies and lack of transparency in the performance, and control, of their activities,
and increased transparency to the general public in relation to the approval of devices.
modification of Directive 90/385/EEC relating to active implantable medical devices in order to align it with the other framework Directives on medical devices.
- 130Existing provisions in the area of the proposal
This proposal aims at amending the already existing Directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices.
- Consultation of interested parties
Beginning in 2003, the primary method of consultation was through the Commission services’ Medical Device Experts Group, comprising the Commission, Member States, Notified Bodies, European standards bodies and industry. The bulk of all comments arose from national authorities and industry.
Authorities, sought clarification on certain areas, such as the appropriate design documentation and design review for particular groups of medical devices, and text to aid better implementation on certain aspects of the Directives, such as clinical evaluation. All substantial comments from authorities were considered and have resulted in either proposed legislative or non-legislative measures.
Industry, criticised the apparent un-harmonised interpretation and implementation of the Directives by Member States, and welcomed any initiative, either legislative or non legislative, that brings clarification and consistency to interpretation and implementation. They also highlighted: clarification of the role of a national authority or the European Medicines Agency (EMEA) when consulted for devices containing a medicinal product or human blood derivative, the provision of electronic labelling and the inclusion of reprocessors of ‘single use’ devices in the definition of ‘manufacturer’.
Here text has been proposed in all areas except reprocessing. In examining the reprocessing issue in detail, including bilateral meetings involving the relevant trade federations, it became clear that it goes far beyond this Directive, and a simple expansion of the definition of ‘manufacturer’, and raises questions that would require further reflection by the Commission services, in consultation with a wider group of stakeholders, to explore possible development of appropriate legislation in this area.
An open consultation was conducted over the internet from 11/05/2005 to 25/06/2005. The Commission received 80 response(s). The results are available on the sectors website: europa.eu.int/comm/enterprise/medical_devices
- Impact assessment
In order to reach the objective of improved coherence and effectiveness of legislation, action was considered in key areas of the Directive namely: Simplification, Better Implementation, Better Conformity Assessment, Legal Certainty (More Binding Rules) in the Directive and Improved Market Surveillance.
As the Directive is already in existence, two basic options are open in order to achieve the objective, either legislative, requiring modification of the current legislation, or non-legislative, including co-ordination of national competencies to create transparency and foster harmonised implementation.
Since the proposal is more regulatory clarification rather than regulatory change, there are no significant economic impacts expected. Similarly there were no environmental impacts identified by the current proposal. However, three principal impacts, health, economic and social impacts, can be singled out which arise not from any specific option chosen, but from the proposal in its entirety:
- Increased clarity will continue to support a high level of public health protection.
- The proposal will provide more transparency and increase the certainty for all market players and, in particular, the public.
- For enterprises and citizens alike, the improved regulatory framework will continue to support fast technical progress to benefit citizens under better clarified conditions for guaranteeing safety and increased trust.
While, certainly, the regulatory clarification will lead to de facto changes in implementation, for those manufacturers who are correctly implementing the Directive there will be no economic effect.
Contents
- LEGAL ELEMENTS OF THE PROPOSAL
- BUDGETARY IMPLICATION
- 141 CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT
- 211 Consultation methods, main sectors targeted and general profile of respondents
- 212 Summary of responses and how they have been taken into account
- ADDITIONAL INFORMATION
- Conformity assessment modules
- Clinical data and evaluation
- Legal certainty regarding scope
- Measures to increase transparency
- Legal basis for better coordination and communication of market surveillance activities
- Clarification regarding medicinal products/medical device provisions
- Devices with an ancillary human tissue engineered product
- Custom-made devices
- Directive 98/8/EC concerning the placing of biocidal products on the market
- 305Summary of the proposed action
This proposal amends Directive 93/42/EEC on medical devices by modifying current provisions, to bring about clarity, or by introducing new provisions, seen as necessary to continue to support the protection of human health. Also, the proposal updates Directive 90/385/EEC on active implantable medical devices to make it coherent with the other Directives on medical devices. Finally, Directive 98/8/EC on biocides is amended to exclude in vitro diagnostic medical devices from its scope, this removes the legal ambiguity that exists, in certain cases, as to which Directive should apply.
- 310Legal basis
The legal basis for the proposal is Article 95 EC Treaty (formerly Article 100A) upon which Directive 93/42/EEC is based.
In order to achieve the objective of abolishing technical barriers to trade and clarification of existing provisions in Directives 93/42/EEC and 90/385/EEC, it is necessary and appropriate to harmonise the laws, regulations and administrative provisions in the Member States on certain aspects concerning the placing on the market or putting into service of medical devices.
- 320Subsidiarity principle
The subsidiarity principle applies insofar as the proposal does not fall under the exclusive competence of the Community.
The objectives of the proposal cannot be sufficiently achieved by the Member States for the following reason(s).
The proposal aims at amending existing Community legislation that harmonized the legal framework for medical devices on Community level in the light of experiences gained by national authorities in its implementation over the past number of years.
Any Member State legislative action would endanger the harmonized framework and present a potential breach of Directives 93/42/EEC and 90/385/EEC.
Community action will better achieve the objectives of the proposal for the following reason(s).
Such amendments to an existing harmonized framework can best be achieved on Community level.
National authorities, through the Medical Device Expert Group Report of June 2002 into the functioning of the medical device Directives, have called for the Commission to propose necessary changes to the Directives on medical devices.
The proposal relates to harmonised legislation for the placing on the market and putting into service of medical devices within the Community and thus cannot be achieved by Member States alone.
The proposal therefore complies with the subsidiarity principle.
- Proportionality principle
The proposal complies with the proportionality principle for the following reason(s).
The proposal is based on experiences gained with the existing framework, it concentrates on changes only where they were perceived by Member States and stakeholders to be necessary for its proper functioning.
The proposal has been subject to an impact assessment and whilst, certainly, the regulatory clarification will lead to de facto changes in implementation, for those manufacturers who are correctly implementing the Directive there will be no economic effect.
- Choice of instruments
Proposed instruments: directive.
Other means would not be adequate for the following reason(s).
Given that the existing framework that is intended to be updated here has been adopted in the form of Directives, a Directive is the most appropriate instrument here that will allow Member States to incorporate the amendments into their existing transposing laws of Directive 93/42/EEC and 90/385/EEC.
4The proposal has no implication for the Community budget.
- Simulation, pilot phase and transitory period
507There was or there will be a transitory period for the proposal.
- 510Simplification
The proposal provides for simplification of legislation.
The proposal adapts the existing legislation in areas where the Commission, Member States and stakeholders saw a need to clarify the legislation to ensure better implementation.
- 550Correlation table
The Member States are required to communicate to the Commission the text of national provisions transposing the Directive as well as a correlation table between those provisions and this Directive.
- 560European Economic Area
The proposed act concerns an EEA matter and should therefore extend to the European Economic Area.
- 570Detailed explanation of the proposal
The proposed legislative modification, developed to reflect the regulatory changes called for in the Commission Communication and subsequently welcomed by Council and Parliament, brings forth either additional or replacement text regarding, in particular:
Here it has been further clarified that, for the conformity assessment of class IIa and class IIb devices under Annex II notified bodies are required to assess, on a representative basis, the design documentation for the device concerned.
In order to clarify and enhance the provisions on clinical evaluation, significant modification was required of Annex X concerning clinical data and its evaluation and to various references to clinical data within the provisions of the Directive, including the definition of clinical evaluation and provision for the possibility to centralise data on clinical investigations in the European databank.
To provide a method to make binding decisions on issues arising at national level, in relation to the misinterpretation of a product as being or not being a medical device, a procedure, based on comitology, has been added to Article 13.
Also, in order to clarify that it is possible for both the Directive on medical devices and the Directive on personal protective equipment to simultaneously apply to a product, such as a surgical glove, it is necessary to delete the reference in Article 1 to the Directive on personal protective equipment to allow both apply.
Article 20 on confidentiality, which previously maintained all information available under the Directive as being confidential, has been relaxed, to allow certain information on all devices to be publicly available and to allow, by comitology, a method of making other information non-confidential, such as summary information on the approval of high risk devices.
The market for medical devices is a global market, with a significant number of devices being imported into the European Union. This has led to an increasing need to coordinate activities of national authorities when applied to issues related to the directive taking place across a number of Member States and/or third countries. Thus it is necessary to introduce a new provision, Article 20a, on cooperation to provide a legal basis for this coordination and international activities.
Devices that incorporate as an integral part a medicinal product or blood plasma derivative are required to be reviewed by a notified body in consultation with a national authority for medicines or the European Medicines Agency (EMEA) as appropriate. These provisions, which are currently contained in Annex I Section 7.4 of the Directive needed modification to reflect the experience gained over the years in their implementation, clarifying both the role of the notified body and the relevant authority.
Provisions are made to include devices with an ancillary human tissue engineered product in the scope. This mirrors the proposed Community legislation on Advanced Therapies and fills a potential regulatory gap.
In order to better evidence the compliance of custom made device manufacturers there is now an explicit requirement for a post market vigilance system reporting to authorities, as already in place for other devices. In order to enhance patient information a requirement is introduced that the Statement under Annex VIII should be also given to the patient and that it must contain the name of the manufacturer.
Amendment of other Directives:
Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices - Alignment of text on certain aspects across all three medical device directives.
The Directive 90/385/EEC on active implantable medical devices, adopted in 1990, was the first in the series of directives on medical devices, however, it has not benefited to the same extent from the market experiences and developments as the Directive 93/42/EEC concerning medical devices and the Directive 98/79/EC on in vitro diagnostic medical devices, which were adopted in later years.
To ensure consistency of interpretation and implementation of the medical device Directives and to update the Directive 90/385/EEC on active implantable medical devices in terms of health protection measures, certain aspects, such as authorised representative, the European Databank, health protection measures, and the application of the Directive 2000/70/EC on medical devices incorporating stable derivates of human blood or human plasma have to be added to Directive 90/385/EC. The latter alignment, on human blood or plasma, results in a significant body of text being inserted into the Directive.
Under this regulatory reform, the Directive on biocides needs to be modified in order to clarify that, alongside the active implantable medical devices and medical devices, also in vitro diagnostic medical devices, now subject of a specific Directive, will be excluded from the scope of the biocides Directive.