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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

  1. Classification: ensure the device is a Class IIb medical device.
  2. Choose Conformity Assessment Route: refer the flow chart below.
  3. Compile the Technical File.
  4. Obtain certification from a Notified Body
  5. Declaration of Conformity.
  6. Appoint an Authorised Representative. (Hold the Tech Files for inspection by the Competent Authority)
  7. 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:
  1. 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;
    or
  2. 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 IV;
      or
    • (ii) the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance);
      or
    • (iii) the procedure relating to the EC declaration of conformity set out in Annex VI (product quality assurance).
There are two routes:
  1. a Notified Body must carry out either an Annex II audit of the full quality assurance system (ISO 13485:2003),
    or
  2. 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); or
    • Audit of the production quality assurance system (Annex V:) ISO 13485:2003 (excluding Design) or
    • Audit of final inspection and testing (Annex VI:) ISO 13485:2003 (excluding Design & Manufacture)
Once the manufacturer has received certification from the Notified Body he may CE mark his products and place them on the market.

Flow Chart of Class IIb MDD




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