Wednesday, June 30, 2021

EU MDR Assessment Routes

Hi friends!!!

 

EU MDR 2017/745 is live now. And it the most trending topic in Medical Device Regulatory Affairs field. Most of the medical device companies are in EU MDR Transition to make sure that they can sell their products in Europe. 


Therefore, it is important for Medical Device QA/RA Professionals to know in detail about EU MDR 2017/745 Assessment Routes.

 

Let’s get into the topic.


EU MDR 2017/745 MEDICAL DEVICE

CLASSIFICATION


As per EU MDR 2017/745, the Medical Device is classified as following.

 

1. Class I.

2. Class Is Sterile, Im Measuring function, Ir Reusable.

3. Class IIa.

4. Class IIb.

5. Class III.

 

Each of the above classified device have separate assessment routes.

 

Let’s discuss in detail about assessment routes.



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EU MDR 2017/745 ASSESSMENT ROUTES


Class I


The conformity assessment for Class I Medical Device shall be done based on Article 52, Clause 7. The Article 52, Clause 7 states the following.


Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III.

 

Class Is, Im, Ir


The conformity assessment for Class Is, Im, Ir shall also be done based on Article 53, Clause 7. The Article 52, Clause 7 states the following about Class Is, Im, Ir.


If those devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX QMS along with Technical Documentation set out in Annexes II and III or in Part A of Annex XI Production Quality Assurance along with Technical Documentation set out in Annexes II and III.

 

Class IIa


The conformity assessment for Class IIa Medical Device shall be done based on Article 52, Clause 6. The Article 52, Clause 6 states the following.


Manufacturers of class IIa devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical documentation as specified in Section 4, Chapter II of that Annex of at least one representative device for each category of devices.


Alternatively, the manufacturer may choose to draw up the technical documentation set out in Annexes II and III coupled with a conformity assessment as specified in Part A, Section 10 Production Quality Assurance or Part B, Section 18 Product Verification of Annex XI. The assessment of the technical documentation shall apply for at least one representative device for each category of devices.

 

Class IIb


The conformity assessment for Class IIb Medical Device shall be done based on Article 52, Clause 4 and Clause 5. The Article 52, Clause 4 and Clause 5 states the following.

 

Clause 4


Manufacturers of class IIb devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical documentation as specified in Section 4 of that Annex of at least one representative device per generic device group.


However, for class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, the assessment of the technical documentation as specified in Section 4 of Annex IX shall apply for every device.


Alternatively, the manufacturer may choose to apply a conformity assessment based on type examination as specified in Annex X coupled with a conformity assessment based on product conformity verification as specified in Annex XI.

 

Clause 5


Where justified in view of well-established technologies, similar to those used in the exempted devices listed in the second subparagraph of paragraph 4 of this Article, being used in other class IIb implantable devices, or where justified in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission is empowered to adopt delegated acts in accordance with Article 115 to amend that list by adding other types of class IIb implantable devices to that list or removing devices therefrom.

 

Class III


The conformity assessment for Class III Medical Device shall be done based on Article 52, Clause 3. The Article 52, Clause 3 states the following.


Manufacturers of class III devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Annex IX. Alternatively, the manufacturer may choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI.


Now I hope you have acquired some knowledge about EU MDR 2017/745 Assessment Routes. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.


NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.


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