DIMDI - Europe - Medical Devices

Europe

Concerning the european market of medical devices you will find comprehensive information about laws, directives, guidelines, harmonised standards, the registration of In Vitro Diagnostic Medical Devices (IVD) and Eudamed, the European database on medical devices.

• Adresses of Competent Authorities and Notified Bodies (Germany, Europe)
• Medical Devices Law (Directives, Guidelines, Standards)

In Vitro Diagnostic Medical Devices (IVD)

Pursuant to Article 10 Paragraph 6 of Directive No. 98/79/EC on in vitro diagnostic medical devices, manufacturers / representatives must transitionally, pending the establishment of a data base accessible to the competent authorities of the Member States and holding the data on all devices moving within the Community, transmit the notifications pursuant to Article 10 paragraph 1 to the competent authorities of each Member State concerned by the placing on the market.

In Germany, the entity that transitionally receives these notifications on behalf of the Federal Ministry of Health is the Deutsches Institut für Medizinische Dokumentation und Information (DIMDI). Manufacturers /representatives will wish to submit these notifications by means of the European form sheet. DIMDI makes this form sheet available on the Internet in two languages (German/English) for download.

• Form for the registration of manufacturers and devices, In Vitro Diagnostic Medical Devices Directive, Article 10 / Formblatt für die Anzeige der Hersteller und der Produkte gemäß Richtlinie 98/79/EG Art. 10 über In-vitro-Diagnostika
  Form IVD (PDF, 43 KB)  |   Form IVD (DOC, 226 KB)

The completed forms can be forwarded to DIMDI either as a file per e-Mail (ivd-eu@dimdi.de) or as hard copy by fax or by mail. The postal address is:

DIMDI
Waisenhausgasse 36-38a
50676 Cologne
Germany
Fax: +49 221 4724-444

Eudamed - European Database on Medical Devices

1997 - 1999 DIMDI was awarded a contract by the European Commission to develop a central European database on medical devices containing:

1. Notifications from manufactures on class I medical devices pursuant to Article 14 of the MDD,
2. Information on certificates granted or denied by notified bodies pursuant to the annexes of the MDD and AIMDD.

EUDAMED has been successfully completed. Due to regulatory and contractual regulations of the European Commission, it was not possible to award DIMDI with a contract for the regular operation, maintenance and expansion of EUDAMED to include data on vigilance and IVD as well.

In late 2000 the Commission decided to take the overall responsibility (DG Enterprise) to redesign EUDAMED based on the results achieved by DIMDI. A working group has been established and funds have been allocated. EUDAMED has been released as of Jan. 2004, accesible to competent authorities only.