Class III medical devices compliance CE Marking

Posted on January 26, 2012. Filed under: Uncategorized |

Steps for Class III medical devices compliance

  1. Classification: ensure the device is a Class III 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 III Medical Devices: Conformity Assessment Routes

The conformity assessment routes for Class III Medical Devices

In the case of devices falling within Class III, 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);
    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).

Class III controls are similar to those for Class IIb devices but additionally require the manufacturer to submit the design dossier to the Notified Body for approval under Annex II and do not allow the Annex III/Annex VI option. 

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),plus that the manufacturer must submit the design dossier to the Notified Body for approval under Annex II, or
  2. a type-examination (Annex IIIplus one of the two 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)

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 III MDD

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