Steps for Class IIa medical devices compliance

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

The conformity assessment routes for Class IIa Medical Devices

In the case of devices falling within Class IIa, other than devices which are custom-made or
intended for clinical investigations, the manufacturer shall, in order to affix the CE marking,

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 declaration of conformity set out in Annex VII,
coupled with either:
o (a) the procedure relating to the EC verification set out in Annex IV;
or
o (b) the procedure relating to the EC declaration of conformity set out in Annex V
(production quality assurance);
or
o (c) the procedure relating to the EC declaration of conformity set out in Annex VI
(product quality assurance).

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:

1. Examination and testing of each product or homogenous batch of products (Annex IV);
or
2. Audit of the production quality assurance system (Annex V:) ISO 13485:2003 (excluding
Design) or
3. Audit of final inspection and testing (Annex VI:) ISO 13485:2003 (excluding Design &
Manufacture) or
4. 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.