The Revision of the directives on medical devices

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 the Council as regards the review of the medical device directives
(A6-0332/2006)
Report: Thomas Ulmer (EPP-ED, DE)
Report adopted by 645 votes in favour to 15 against with 4 abstentions, with amendments on March 29, 2007

In the final report, 4 amendments concerning the MDD 93/42/EEC and 1 concerning the AIMDD 90/385/EEC were adopted regarding the Role and Duty of the European Authorized Representative.

O.E.A.R.C. is proud of this achievement, the result of an intense 3 years of activity by our European Association of Authorised Representatives (E.A.A.R), since the first working document came out on March 22, 2004 for review and remarks by all stakeholders: the EU Commission, the EU Member States, the Notified Bodies and the Industry representatives (i.e. the E.A.A.R)

To summarize the amendments concerning the role and duty of the EC REP, adopted on March 29, 2007, are as follows:

“It is necessary to introduce an obligation for such manufacturers to designate an authorized representative for all classes of devices: The obligation for a non EU manufacturer to appoint an EC REP for all classes of medical devices.” Amendment 18 Recital 14. Comment: A major clarification confirming the obligation of non EU manufacturers who do not have a legal identity within the EU territory for all classes of medical devices to appoint an EC REP.

“The authorized representative should also be available for any queries” (from the EU Member States Competent Authorities) Amendment 19, Article 1, point 3 – Article 10a, paragraph 2, subparagraph 2 (AIMDD 90/385/EEC). Comment: The confirmation of the role and duty of the EC REP as (Vigilance) contact point with the EU Member States Competent Authorities.

“Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate for this device a single authorized representative in the European Union”. Amendment 42 Article 2, Point 7 – Article 14, paragraph 2, subparagraph 1 (MDD 93/42/EEC. Comment: The confirmation of the obligation for a non EU Manufacturer to appoint 1 single EC REP for a product (but the manufacturer does not need necessarily to designate the same EC REP for his entire range of medical devices)

“As regards reprocessing, manufacturers and/or authorized representatives must declare their products uniformly within the European Union.”. The manufacturer and/or his representative shall provide a detailed documentation on how the device can be safely reprocessed.” Amendment 59 Annex II Point I (A A) – Annex I, Section 6a (new) (MDD 93/42/EEC). Comment: Besides the fact that it shows very clearly the responsibility of the manufacturer regarding the classification of the usage of their medical devices and the requirement of a clear justification when the device is designed for single use, this amendment makes very clear the role and duty of the appointed EC REP in regards to making available such justification documents to the EU Member States Competent Authorities.

“The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorized representative established in the Community or the importer must make this documentation, including the declaration of conformity, available to the national authorities for inspection for a period of at least five years from the date of manufacture.” Amendment 70 Annex II, Point 7 (A) – Annex VII, section 2 (MDD 93/42/EEC) Comment: The aim of this last amendment is to reinforce the availability of the technical documentation to the EU Competent Authorities. Although a single authorized representative has to be designated, making the documentation available to the Competent Authorities, the EU still gives an additional way of getting this crucial information by adding the importer “into the loop”.

Amendment 70 Annex II, Point 7 (A) – Annex VII, section 2 (MDD 93/42/EEC) Comment: The aim of this last amendment is to reinforce the availability of the technical documentation to the EU Competent Authorities. Although a single authorized representative has to be designated, making the documentation available to the Competent Authorities, the EU still gives an additional way of getting this crucial information by adding the importer “into the loop”.

The amended versions of the MDD 93/42/EEC, AIMDD 90/385/EEC and 98/8/EC should be published in the Official Journal of the European Community after the next Health Council session due to take place at the end of May 2007. Currently it seems more likely that the amended texts will be adopted during the Health Council session in September. The time frame for implementation into the 27 EU Member States’ national legislation and transition period should be first a period of 15 months for transposition and an additional period of 15 months for transition.

Last updated Dec 28, 2008

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