EU MDR Update: How To Get a New Medical Device Certified? [Flow Charts]

If you are developing a new medical device for sale in the EU, the EU MDR update affects you as you must now get it certified to the EU MDR regulation. 

But what is the path to get it certified? It very much depends on its ‘class’. 

In a previous article, we explained how to confirm if your product is considered ‘medical’ in the European Union. We also described the logic applied to determine how medical devices are classified.

In this article, let’s look at the path to certification for the different classes of medical devices in this new EU MDR update.

1. Conformity assessment path for a Class I medical device 

It is relatively straightforward, as this product class is not considered very risky. No notified body is involved. 

Here are the important requirements to follow, in the right order:

1. See Annex I of the MDR – it states the safety and performance requirements.
2. See Annex II of the MDR – it demands technical documentation that proves the requirements of annex I have been met.
3. See Annex IV of the MDR – it is about the declaration of conformity, which is issued by the manufacturer and signed by someone of responsibility in the company.
4. See Annex V of the MDR – it is about the CE mark, which is affixed on the product and package. (As I wrote before, no notified body is involved for Class I products.)

2. Conformity assessment path for a Class I s, I m & I r medical device

These devices carry more risk than Class I devices because they’re Sterile, Reusable, or have a Measuring function, hence the letters.

The requirements are listed below:

1. See Annex I of the MDR – it states the safety and performance requirements.
2. See Annex II of the MDR – it requests certain technical documentation.
3. The manufacturer has to choose between 2 approaches:

• As described in annex IX chapters 1 to 3: a conformity assessment (by a notified body) will have to be completed on the quality management system (QMS) against ISO 13485 and on the technical documentation, but to a limited extent (e.g. for a class I s device: it will be limited to what is related to sterilization).
• As described in annex XI part A: a conformity assessment (by a notified body) will have to be completed on the production quality system (excluding the design & verification activities).

4. See Annex IV of the MDR – it is about the declaration of conformity.
5. See Annex V of the MDR – it is about the CE mark, which is affixed on the product and package. The notified body number will be attached to the CE mark.

3. Conformity assessment path for a Class IIa medical device

1. See Annex I of the MDR – it states the safety and performance requirements.
2. See Annex II  – it requests certain technical documentation.
3. The manufacturer has to choose between 3 approaches:

• As described in annex IX: a conformity assessment (by a notified body) will have to be completed on the QMS against ISO 13485 and on the technical documentation.
• As described in annex XI part A: a conformity assessment (by a notified body) will have to be completed on the production quality system (excluding the design & verification activities).
• As described in annex XI part B: a verification (by a notified body) will have to be completed on product conformity (based on 100% testing), for example on a small production batch.

4. See Annex IV of the MDR – it is about the declaration of conformity.
5. See Annex V of the MDR – is about the CE mark, which is affixed on the product and package. The notified body number will be attached to the CE mark.

4. Conformity assessment path for a Class II b medical device

The requirements are:

1. See Annex I of the MDR – it states the safety and performance requirements.
2. See Annex II of the MDR – it requests a certain technical documentation.
3. The manufacturer has to choose between 4 approaches:

• As described in annex IX: a conformity assessment (by a notified body) will have to be completed on the QMS against ISO 13485 and on the technical documentation. Then, if the MD is active and it administrates and/or removes a medicinal product, section 5 of annex IX applies, and there are extra special procedures. 
• As described in annex IX: same as above, but the MD is not active and does not administrate or remove a medicinal product: no need for the extra special procedures.
• As per annex X (conformity assessment by ‘type examination’), production is audited and a representative sample of production is tested by the notified body. And, as described in annex XI part A, a conformity assessment (by a notified body) will have to be completed on the production quality system (excluding the design & verification activities).
• As per annex X, production is audited and a representative sample of production is tested by the notified body. And, as described in annex XI part B, a verification (by a notified body) will have to be completed on product conformity (based on 100% testing), for example on a small production batch.

4. See Annex IV of the MDR – it is about the declaration of conformity.
5. See Annex V of the MDR – it is about the CE mark, which is affixed on the product and package. The notified body number will be attached to the CE mark.

5. Conformity assessment path for a Class III medical device

The requirements are:

1. See Annex I of the MDR – it states the safety and performance requirements.
2. See Annex II of the MDR – it requests certain technical documentation.
3. The manufacturer has to choose between 4 approaches:

• As described in annex IX: a conformity assessment (by a notified body) will have to be completed on the QMS against ISO 13485 and on the technical documentation. Then, if the MD is implantable, medicinal, human origin, animal origin, or absorbed/dispersed, section 5 of annex IX applies, and there are extra special procedures. 
• As described in annex IX: same as above, but it is not implantable, medicinal, human origin, animal origin, or absorbed/dispersed: no need or the extra special procedures.
• As per annex X, production is audited and a representative sample of production is tested by the notified body. And, as described in annex XI part A: a conformity assessment (by a notified body) will have to be completed on the production quality system (excluding the design & verification activities).
• As per annex X, production is audited and a representative sample of production is tested by the notified body. And, as described in annex XI part B: a verification (by a notified body) will have to be completed on product conformity (based on 100% testing), for example on a small production batch.

4. See Annex IV of the MDR – it is about the declaration of conformity.
5. See Annex V of the MDR – it is about the CE mark, which is affixed on the product and package. The notified body number will be attached to the CE mark.

Now, we hope your path forward is clear.

We referred you to some sections of the new MDR a number of times, so please refer to it for further information about the EU MDR update and how it affects you.

Explore even more information about the EU Medical Device Regulation

• How The EU MDR Will Change The Medical Device Industry Forever [Podcast]
• New EU MDR: Who Are The “Economic Operators” For Imported Devices?
• EU MDR Changes: Are You Selling a Medical Device, and What Class Is It?

A disclaimer…

We at Sofeast are not lawyers. What we wrote above is based only on our understanding of the regulatory requirements. We do not present this information as a basis for you to make decisions, and we do not accept any liability if you do so. Please consult a lawyer before taking action.