Hospital Decontamination and the MDR - Technical Files, UDI and PMS

dchinny

Registered
A trust that I have worked with for some time intends on supplying procedure packs (Article 22) and supplementary items to health clinics and would then be considered as placing devices on the market. We are now unable to use Article 5.5 of the MDR and would be considered as the legal manufacturer. The Trust is ISO13485 accredited and also to Article 12 of the MDD. Can anyone clarify the extent to which the MDR or similar UK adopted regulation, would apply in terms of Technical Files, UDI and PMS? Thanks in advance
 

chris1price

Trusted Information Resource
I don't see a specific requirement for technical files for procedure packs, however, in addition to the statement referred to in Article 22-2, I would suggest a file describing how the requirements of paragraph 2 have been met.

Regarding UDI, take a look at MDR Article 26 para 2 and Annex VI 3.7

2. Before placing on the market a system or procedure pack pursuant to Article 22(1) and (3), that is not a custom- made device, the natural or legal person responsible shall assign to the system or procedure pack, in compliance with the rules of the issuing entity, a Basic UDI-DI and shall provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that system or procedure pack.

Also see Annex VI, Para 3.7, and 6.3, and maybe other sections.

I would say, Post Market Surveillance is a given, it should be performed by all manufactures.

If you are a UK hospital trust, you are probably not the only ones facing this problem. Is there a NHS group who can advise?
 

dgrainger

Trusted Information Resource
UK legislation is still based on MDD. This is the only guidance on post Transition period legislation at the moment:
Medical devices: EU regulations for MDR and IVDR


Update on delay to full implementation
The European Parliament and Council have approved a proposal to delay the full implementation of the Medical Device Regulation 2017/745 (MDR) for one year to 26 May 2021. This means that the full applicability of the MDR will fall outside of the transition period agreed with the EU.​
We are taking steps to plan for after the end of the transition period. We will provide guidance on this in due course in light of Government decisions required on the future of UK regulation. All decisions on regulations will be taken with a view to prioritising patient safety and ensuring patient access for medical devices.​
In the meantime, the existing regulatory requirements should continue to be met.​
 

dchinny

Registered
Hi Chris, this is is really helpful
Kind of suggests they will have a lot of work to do in terms of sorting UDI procedures etc, I think that is the bigger challenge than any Tech File stuff.
Unfortunately, I'm not aware of any NHS groups looking at this. Most trusts have decided to stop doing it or are being very quiet about doing it.
 
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