Steps for Class IIa medical devices compliance
- Classification: ensure the device is a Class IIa 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 IIa Medical Devices: Conformity Assessment Routes
The conformity assessment routes for Class IIa Medical Devices
As for Class I, the manufacturer declares conformity with the provisions of the Directive
and Regulations and ensures that his products comply with relevant Essential
Requirements. However, for Class IIa products, this declaration must be backed up in all
cases with conformity assessment by Notified Body. This assessment may, at the
manufacturer’s choice, consist of:
- 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) or
- Audit of the full quality assurance system (Annex II) ISO 13485:2003
Once the manufacturer has received certification from the Notified Body he may CE mark
his products and place them on the market.
FAQ/Q&A: Questions and Answers about CE Marking of Medical Devices
About CE Marking:
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