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:
o (i) the procedure relating to the EC verification set out in Annex IV;
or
o (ii) the procedure relating to the EC declaration of conformity set out in Annex V
(production quality assurance);
or
o (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:
o Examination and testing of each product or homogenous batch of products
(Annex IV); or
o Audit of the production quality assurance system (Annex V:) ISO 13485:2003
(excluding Design) or
 o 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.