Obelis European Authorized Representative Center"CE Marking Consultants with a Reputation for Excellence"
Directives that amended the 93/42/EEC:
MD manufactured utilizing tissues of animal origin:
b) Directive 2007/47/EC:
The new directive 2007/47/EC has implications not only for manufacturers who sell medical devices in the EU but for the medical device industry as a whole.
(I)The directive 2007/47/EC amends the following directives: AIMDD 90/385/EEC, MDD 93/42/EEC and the directive 98/8/EC concerning the placing of biocidal products in the European Economic Area. Manufacturers will need to be aware of several essential changes in order to ensure compliance with these new EU regulations.
The new directive modifies several key issues regarding medical devices and amends three significant medical device directives. It is important that manufacturers understand their new responsibilities to guarantee their proper compliance in the EU. Obelis European Authorized Representative Center (O.E.A.R.C.) not only serves as an authorized representative for non-EU manufacturers but also helps make sure manufacturers are as up to date as possible regarding essential changes to the directives.
(II) European Authorized Representative role requirement re-enforced.
4 amendments concerning the MDD 93/42/EEC and 1 concerning the AIMDD 90/385/EEC were more particularly adopted regarding the requirement of appointing a European Authorized Representative.
“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, subparagraphs 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 EU Commission released a “consolidated version” of the MDD 93/42/EEC available from website library (Please note that a “consolidated version” has no legal validity as only the above mentioned directives adopted by the EU parliament have)