Conformity assessment route options under the UK MDR 2002 (2002 SI No. 618), as amended

[jansayshello]

Hello,

The company I work for is planning the regulatory strategy for a Class IIa medical device ("General Medical Device"), which we are developing for one of our customers.

It is intended to be placed on the market in Great Britain (GB) with UK (UKCA) marking.

We have an ISO 13485:2016-accredited QMS, including 7.3 design and development within the scope.

We may end up becoming the legal manufacturer for the device, or our customer may end up developing their own QMS and becoming the legal manufacturer – this is yet to be determined.

I understand that the conformity assessment route options for class IIa devices in GB include:

1. examination and testing of each product or homogenous batch of products (Part II of the UK MDR 2002, Annex IV (as modified by Part II of Schedule 2A to the UK MDR 2002)
2. audit of the production quality assurance system (Part II of the UK MDR 2002, Annex V (as modified by Part II of Schedule 2A to the UK MDR 2002))
3. audit of final inspection and testing (Part II of the UK MDR 2002, Annex VI (as modified by Part II of Schedule 2A to the UK MDR 2002))
4. audit of the full quality assurance system (Part II of the UK MDR 2002, Annex II (as modified by Part II of Schedule 2A to the UK MDR 2002))

– transposing and modifying the requirements for conformity assessment from 93/42 EEC, as amended by 2007/47 EEC.

1. Could someone please help me understand the key differences between these route options?
2. From a commercial and regulatory perspective, in what situation(s) would you choose one route over another?
3. Does the complexity of the device and/or production process influence this decision?

Thanks in advance,

Jan

 

[Ronen E]

Hello,

The company I work for is planning the regulatory strategy for a Class IIa medical device ("General Medical Device"), which we are developing for one of our customers.

It is intended to be placed on the market in Great Britain (GB) with UK (UKCA) marking.

We have an ISO 13485:2016-accredited QMS, including 7.3 design and development within the scope.

We may end up becoming the legal manufacturer for the device, or our customer may end up developing their own QMS and becoming the legal manufacturer – this is yet to be determined.

I understand that the conformity assessment route options for class IIa devices in GB include:

1. examination and testing of each product or homogenous batch of products (Part II of the UK MDR 2002, Annex IV (as modified by Part II of Schedule 2A to the UK MDR 2002)
2. audit of the production quality assurance system (Part II of the UK MDR 2002, Annex V (as modified by Part II of Schedule 2A to the UK MDR 2002))
3. audit of final inspection and testing (Part II of the UK MDR 2002, Annex VI (as modified by Part II of Schedule 2A to the UK MDR 2002))
4. audit of the full quality assurance system (Part II of the UK MDR 2002, Annex II (as modified by Part II of Schedule 2A to the UK MDR 2002))

– transposing and modifying the requirements for conformity assessment from 93/42 EEC, as amended by 2007/47 EEC.

1. Could someone please help me understand the key differences between these route options?
2. From a commercial and regulatory perspective, in what situation(s) would you choose one route over another?
3. Does the complexity of the device and/or production process influence this decision?

Thanks in advance,

Jan

Q3: Not really / not directly / not usually

Q1+Q2:
It's mostly a regulatory issue; not really a commercial one. You wouldn't normally want to go with option 1 unless your production is of low unit count. It's cumbersome and quite rigid in most "normal" cases, so you'd normally consider it only if the "normal" routes (2-4) pose serious difficulties - which I wouldn't normally expect.
Options 2-4 are related to the activities you do. If you'll end up being the legal Manufacturer, you won't really have on option but to go with option 4, because you also do the design and development. If your client ends up as legal Manufacturer, there might be some wiggle room - it will depend on who will "own" the design. Options 2 & 3 are for Manufacturers who don't do design and development; Option 2 would be the "normal" one in that case. I suspect that although option 3 is perfectly legal, no certification body will endorse it anymore, or at least they will frown upon the choice. I don't really know what the atmosphere around that is in the UK in 2022, but historically this route existed under the MDD and under that scheme option 3 was typically not promoted (to put it lightly).