Issuing Product Certificates for CE Marking

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI  February 1998 Column

HELP DESK

Harald Rentschler, president of Medical Device Certification GmbH (Memmingen, Germany), explains how several notified bodies can issue company product certificates for CE marking.

Is it true that, at least in principle, a legal manufacturer (as defined in the European Medical Devices Directive) may choose notified body A to obtain CE marking for one product family (e.g., Class 2A nonactive devices) and notified body B for another product family (e.g., Class 2A active devices produced with a copacker EN 46002 certified for this class)?

If yes, which notified body will issue the product certificate for the active devices (in this case, according to MDD/annex V)? Both product families need to become part of the manufacturer's EN 46002—certified quality system, but is it possible to include both product families on the same quality system certificate?

There is no limit on the number of notified bodies a company may use if it manufactures different devices. However, a provision of Medical Devices Directive 93/42/EEC states that for any one device, only one application can be filed with a notified body. This requirement leads to the conclusion that it is not possible to cover all devices under one certificate if different product applications have been lodged with different notified bodies.

The certificate for the active devices can be issued by notified body B even though other devices are being certified by notified body A. Notified bodies may consider the results obtained by other notified bodies during their assessments to avoid reexamining certain general aspects.

With respect to a voluntary certification according to the EN 46000 series, all activities of the company can be covered by one certificate.

"Help Desk" solicits questions about the design, manufacture, regulation, and sale of medical products and refers them to appropriate experts in the field. A list of topics previously covered can be found in our Help Desk Archives. Send questions to Help Desk, MD&DI, 11444 W. Olympic Blvd., Ste. 900, Los Angeles, CA 90064, fax 310/445-4299, e-mail [email protected]. You can also use our on-line query form.

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