The Latest EU Regulatory Developments

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 on the market. Manufacturers will need to be aware of several essential changes in order to ensure compliance with these new EU regulations.

1. First and foremost, manufacturers are required to designate a European authorized representative for all classes of medical devices and the same one for the same category of medical devices ("single authorized representative"). The authorized representative is appointed by the manufacturer and deals with the compliance of devices in relation to the Directives.
2. Devices will now be classified by their primary mode of action and not by intended use.
3. Manufacturers of Class I sterile and/or measuring medical devices will be given the option of using the full quality assurance conformity assessment module allowing more flexibility when choosing a compliance route.
4. Software intended for use by the manufacturer for medical purpose(s) is confirmed as a medical device. Furthermore, if the software is a stand alone or is incorporated in a device the validation of the software is required.
5. Clinical data is required for ALL devices regardless of classification
6. Custom-device manufacturers are subject to a post market production review system involving incident reporting to the authorities.
7. Manufacturers must retain their records for 5+ years for the competent authorities and manufacturers of implantable devices for 15 years for administrative purposes.
8. Manufacturers who use third parties to carry out the design and manufacturer of devices must demonstrate that the controls are adequately applied to the third party to ensure efficient quality system operation.
9. Explicit prior authorization concerning conformity and an assessment of the design documentation is required for Class III devices to be placed on the market. It is necessary that the Notified Body reviews the design documentation for the medial device(s) to ensure proper compliance.
10. All surgically invasive devices intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body are classified as Class III devices. The definition of the central circulatory system has now been expanded (see Annex X).
11. Regulatory data in accordance with this Directive shall be stored in a European databank accessible to the competent authorities. This regulatory data includes information on registration, vigilance reports and certificates as well as data relating to clinical investigations. The data should be forwarded in a standardized format (Article 10b).
12. Devices that use human tissue, blood and plasma will fall under the scope of Directive 2001/83/EC and will be classified as Class III.
13. Manufacturers must now clearly indicate the date of issue or the latest revision of the instructions for use.
14. Manufacturers must provide information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. A manufacturer's indication of single use must be consistent across the EU and the information must be made available to the user upon request.

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 an 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, 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".

O.E.A.R.C. has had over 19 years of experience providing superior regulatory consultancy services to manufacturers worldwide. Furthermore, O.E.A.R.C. is a knowledgeable and professional source for information concerning this directive and many other European directives. Obelis' regulatory experts provide guidance on compliance as well as assist manufacturers with important documentation required by the relevant Competent Authorities and Notified Bodies. To receive a copy of the Directive, please feel free to contact us at mail@obelis.net.