By: Ludger Möller

News and Views

May 2005
Content:
Revision of the Medical Device Directives

Dear Valued Client

Since 2001, the Medical Device Directive is being discussed at the European Commission’s Medical Device Experts Group (MDEG). A report on the functioning of the Medical Device Directive was issued by the MDEG in June 2002. The commission issued a status report in May and July 2003 to the Council and the European Parliament. Those documents can be found on the European website at http://europa.eu.int/comm/enterprise/medical_devices/policy/review_process.htm.
The overall result of this review was that the directives are functioning but that there was still room for improvements. In October 2004, a consolidated text was provided to the Commission which was further discussed. The result can now be found on http://europa.eu.int/comm/enterprise/medical_devices/consult.htm#back where it is available for public comment until June 25, 2005. The comments can be submitted directly via the European website.

MDSS view
Many comments on this document may be received by the European Commission and, as always when legislation is up for public comment, specific points may be controversial. I assume that comments are appreciated, but the chance of them being taken into consideration is very slim due to the fact that this document has already been reviewed thoroughly and discussed with the expert group to great length. As you may know, the expert group consists not only of governmental agencies, but also of industries associations.

WEEE and RoHS
There are two new directives on the horizon being transposed in the European member states.
DIRECTIVE 2002/96/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 27 January 2003 on waste electrical and electronic equipment (WEEE)
and
DIRECTIVE 2002/95/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS)
The documents can be found at
http://europa.eu.int/comm/environment/waste/weee_index.htm

The WEEE directive is applicable to medical device manufacturers. However, implanted and infected medical devices are excluded. The transposition is scheduled for August 13, 2005. The member states shall ensure that they have as well the appropriate systems implemented, e.g. registration or selection facilities etc. The purpose of this directive is that electrical and electronic equipment can be returned free of charge. This puts the burden on the manufacturer to take care of the return of the product. Each member state will most likely implement a different system. The directive does not indicate how member states shall fulfill their obligation. The directive requires that certain amounts of waste shall be accounted for. At this point MDSS does not provide additional service for those directives. Please contact your importer on how they are being confronted with this matter today. It may highly depend on how they want to handle the obligation, e.g. the return of the product or the payment of fees to collection facilities. MDSS initiated a review of the different countries with the Association of European Representatives. This review should include the handling of the WEEE in the major European markets.

The RoHS directive is not applicable to medical devices (see Article 6) as of today. In the directive it is indicated that in February 2005 a decision should be reached whether medical devices are covered under the RoHS directive. According to our information, a proposal to include medical devices has not been given. The commission, in order to make an informed decision, is planning to conduct a study on the impact of this directive on medical devices. This may take a number of years.

MDSS view:
In our opinion this is a wise decision because it may not be possible to immediately exchange certain hazardous substances from medical devices if the reliability of certain components has not been fully evaluated. As a consequence, certain products would not be available anymore. This is certainly of no concern to the consumer market and new replacement components will be developed rather quickly for that market. Due to the much greater consumer market, medical devices may automatically comply in the near future because you may not be able to purchase any hazardous components anymore. If your suppliers operate in other markets as well, they will ensure that those hazardous substances are going to disappear. However, please keep an eye on this directive if the opinion in the commission changes and a different decision may come forward.

It goes without saying that if you have any questions regarding the above directives, we will be pleased to assist. If you would like us to conduct further research in any of the above matters, we are happy to do so.

Review on contact information:
It is time to verify our main contacts in your organization again. Please understand that it is of critical nature that we have full contact information of a first and second contact here on file in order to ensure timely notification in case the authority contacts MDSS. In particular, I would like to ask you to include the corresponding e-mail addresses. In the future we will send out the “News and Views” via e-mail. So far I have been of the opinion that there is a higher possibility of information being read if it is provided via a hard copy. However, with all the links it will certainly be nicer to have the information in an e-mail format.

Ludger Möller
Medical Device Safety Service GmbH

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