|As of 21 March 2010, a Single EU/EC European Authorised/Authorized Representative must be designated by a non-EU manufacturer of medical devices as required by directive 2007/47/EC, are you ready?
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Steps for Class IIb medical devices compliance
- Classification: ensure the device is a Class IIb medical device.
- Choose Conformity Assessment Route: refer the flow chart below.
- Compile the Technical File.
- Obtain certification from a Notified Body
- Declaration of Conformity.
- Appoint an Authorised Representative. (Hold the Tech Files for inspection by the Competent Authority)
- Vigilance and Post Market Surveillance. (affix CE marking & market the products)
Class IIb Medical Devices: Conformity Assessment Routes
The conformity assessment routes for Class IIb Medical Devices
In the case of devices falling within Class IIb, other than devices
which are custom-made or intended for clinical investigations, the
manufacturer shall, in order to affix the CE marking, either:
There are two routes:
- follow the procedure relating to the EC declaration of conformity
set out in Annex II (full quality assurance); in this case, point 4 of
Annex II is not applicable;
- follow the procedure relating to the EC type-examination set out in
Annex III, coupled with:
- (i) the procedure relating to the EC verification set out in Annex
- (ii) the procedure relating to the EC declaration of conformity set
out in Annex V (production quality assurance);
- (iii) the procedure relating to the EC declaration of conformity set
out in Annex VI (product quality assurance).
Once the manufacturer has received certification from the Notified Body he may CE mark his
products and place them on the market.
- a Notified Body must carry out either an Annex II audit of the full
quality assurance system (ISO 13485:2003),
- a type-examination (Annex III) plus one
of the three options given here:
- Examination and testing of each product or homogenous batch of products (Annex IV);
- Audit of the production quality assurance system (Annex V:) ISO 13485:2003 (excluding
- Audit of final inspection and testing (Annex VI:) ISO 13485:2003 (excluding Design &
FAQ/Q&A: Questions and Answers about CE Marking of Medical Devices
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