CE Mark, Part 2, Conformity Assessment Pathways

Posted by Bob Duffy on July 1, 2018 in Device Tips, Regulatory & Standards Compliance

CE Mark, Classification, EU, Medical Device Directive, Quality Management System

This is the 2^nd Device Tip in the series about obtaining and CE Mark for a Medical Device to be sold in the EU.  This tip will provide some basic information about what are known as “conformity assessment pathways”, that is, different ways a company can get a CE Mark depending on two factors:

1. The Classification of the product, and
2. The Certification/Registration status of the company’s Quality Management System (QMS).

We’ll cover the Certification/Registration of the company’s Quality Management System (QMS) in the next DT in this series.

There are four major Classifications of Medical Devices under the EU Medical Device Directive (MDD):

1. Class I
2. Class IIa
3. Class IIb, and
4. Class III

The Classification for a specific Medical Device is determined by applying what are called ‘Classification Rules’ that are listed in Annex IX of the MDD (93/42/EEC).  It’s really not hard to go through the Classification Rules provided in Annex IX section III, using the definitions provided in Annex IX section I and the process described in Annex IX section II.

So here’s the tip:

Determine the classification for your device following Annex IX of the MDD.  Be sure to note the Rule you use to determine the Classification

More Info

There are (18) Rules for EU Medical Device Classification listed in Annex IX section III.  These Rules determine the EU Medical Device Classification considering such factors as:

1. Whether the device is invasive or not
2. Whether they are active or not
3. What the device is intended to be used for
4. Whether the device is intended to be connected to other devices
5. The duration of use
6. Whether they are single-use or reusable
7. Whether they are diagnostic or therapeutic
8. Whether they administer medicine, body liquids or other substances
9. Whether they supply energy, and the type of energy they supply
10. Whether they are implantable
11. What types of things they diagnose, monitor or correct
12. Whether they incorporate medicinal substances
13. Whether they incorporate animal tissues or derivatives

This list is not comprehensive – one must use the actual Rules, definitions and process described in the MDD Annex IX .