Medical Devices Directive Review
This article was originally published in RAJ Devices
Executive Summary
Work continues ahead of first reading in European Parliament and Council
Work continues ahead of first reading in European Parliament and Council
The European Parliament's Environment, Public Health and Food Safety Committee (ENVI) is continuing its scrutiny of the European Commission proposals to amend the medical devices directives.
A draft report by Thomas Ulmer, ENVI's rapporteur on the proposals, makes a number of recommendations, covering, for example, advanced therapy products, the definition of a medical device, classification issues, legal certainty, reprocessing and bureaucracy. Mr Ulmer's proposals are outlined below.
Advanced therapy products
Only products which contain non-viable tissues and cells with an ancillary action to that of the device on the human body should be considered medical devices. All other combined products should be classified as advanced therapy products.
Definition of a medical device
- the text of the definition of a medical device, the term “software” should be changed to “diagnostic software” and the term “for medicinal purposes” should be removed as it may create uncertainty and result in certain products being excluded from the directive.
Classification
An additional annex should be made to the Medical Devices Directive (MDD) to contain a list of information on individual products to aid the difficult task of classifying products in a clear and un-bureaucratic way.
Legal certainty
It is important that manufacturers are fully involved in decisions involving the classification of products, as Article 1(2) (a) of the MDD states that the purpose intended by the manufacturer is an integral factor in the definition of a product as a medical device. As the European Court of Justice has ultimate jurisdiction over whether a product is a medical device, it should be ensured that manufacturers have the option of bringing a complaint directly before the European Court of Justice.
Reprocessing
Manufacturers must declare their products uniformly within the European Union in order to end situations where one product can be described as single-use in one country and multiple-use in another.
Bureaucracy
Manufacturers should be required to keep documentation for inspection purposes for a five-year period as it is highly unlikely that an inspection of documents will happen outside this period.
Timetables and the European Council
The ENVI committee has until 6 September 2006 to make additional amendments to its report2. The report is scheduled to be adopted in the committee meeting of 3-4 October 2006 and should then go to the parliament plenary session in November 2006.
The European Council's working party on pharmaceuticals and medical devices is also continuing to examine the proposals. It has now met 14 times, most recently on 10 July 2006, to discuss the proposal to identify issues for further consideration3. It has identified broad agreement on many elements of the proposal including the provisions aimed at reinforcing conformity assessment and the provisions responding to the rising role of software in medical devices.
Discussions have also focused on the introduction of the notion of “medical purpose” in the definition of a medical device, the place of the active implantable medical device directive (Directive 90/385/EC) in the directives and the identification of regulatory gaps as regards products of human or animal origin in medical use with a primary mode of action. A council spokesperson confirmed that the possibility of removing non-viable human tissue healthcare products from the European Commission's proposed advanced therapies regulation and bringing them under the scope of the medical devices legislation was under review4.
The working party will continue to meet to discuss outstanding issues.
The Council has scheduled the meeting of the Employment, Social Policy, Health and Consumer Affairs Council of 30 November - 1 December 2006 as the date for achieving political agreement, providing the European Parliament's opinion is available by then.
References
1. Draft report on the proposal for a directive of the European Parliament and of the Council amending Council Directives 90/385/EEC and 93/42/EEC and Directive 98/8/EC of the European Parliament and of the Council as regards the review of the medical device directives, Committee on the Environment, Public Health and Food Safety, www.europarl.europa.eu/meetdocs/2004_2009/documents/pr/615/615942/615942en.pdf
2. ENVI News, 6 July 2006, www.europarl.europa.eu/comparl/envi/pdf/envinews/2006/200610.pdf
3. Personal communication, council of the European Union, 18 May 2006
4. Personal communication, council of the European Union, 12 July 2006
5. Employment, Social Policy, Health and Consumer Affairs council press release, 1-2 June 2006, www.consilium.europa.eu/ueDocs/cms_Data/docs/pressdata/en/lsa/89830.pdf