Legal Framework in reference to the 2007/47/EC - after March 21st 2010 – NEW!

By Dr. Peter N. Ruys – Senior Regulatory Expert for Obelis s.a.
The certification of medical devices in the EU is based upon three directives – MDD, AIMD and IVD.

The directive 93/42/EEC has been modified 5 times in the past while the most recent amendment was via directive 2007/47/EC. Based upon the discussions between NB’s and competent authorities the commission has issued a guidance document how to deal with the compliance with the modifications in directive 2007/47/EC.

After March 2010, the Notified Body will renew or issue new certificates based upon the 93/42/EEC including all modifications of this directive. This was already the case after earlier modifications. The certificates will not refer to directives in which the modifications of the 93/42 /EEC have been established. The manufacturer shall issue a new declaration of conformity dated March 21st 2010 or later to state that he complies with the directive in place at that moment (meaning with all the modifications). Whenever new requirements are established the manufacturer shall update his declaration once again.

As of March 21st 2010, agreements such as between NB and the manufacturer or between the manufacturer and his Authorized Representative, a reference to 2007/47/EC is not needed while it can even be considered to be confusing if the other modifications have not been mentioned as well – as such, it is recommended that such agreements signed after March 21st shall make reference to the current valid directive only without mentioning all modifications to that directive - Old agreements will not require to be updated to reference to the directives with modifications.

To download the transitional period guidance document – please click here.

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