1. What is MDR?

MDR is “Medical devices Regulation”, specifically referring to the European Union medical device Regulation (EU) 2017/745. MDR, which indicates the CE certification of medical devices to the EU.

This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. This Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the Union.

• ‘Medical Device’ in this regulation means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes.

• ‘Accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s).

In general, devices should have the CE marking indicating their compliance with this Regulation in order for them to be freely circulated within the EU and put into use for their intended purpose.

2. How to apply MDR?

a. With CE MDD certification

All CE MDD directives issued after May 25, 2017, despite the expiration of the certificate, can still be put on the market after meeting the relevant conditions. However, MDR certification must be obtained before December 31, 2028 at the latest.

b. No CE certification before

1. Analyze the characteristics of the device and determine whether it belongs to the MDR or IVDR (In Vitro Diagnostic Device Regulation)
2. Determine the classification of the device (Class I, Class IIa, Class IIb, Class III)
3. Choose the appropriate conformity assessment procedure
4. Choose a notified body
5. Confirm the applicable basic requirements/relevant harmonized standards and complete the relevant documents
6. EU authorized representative
7. Pass the conformity procedure of the notified body
8. Draft a declaration of conformity and affix the CE mark

The notified body will audit every year to ensure that the medical device complies with the MDR requirements.