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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





Medical Devices MDD conformity assessment procedures table







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FAQ/Q&A: Questions and Answers about CE Marking of Medical Devices About CE Marking:

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