UK MDR Transition Periods, Audit Tips and Compliance Matrices

Hello all, this week we’re discussing the UK MDR consultation, a small audit tip that I always find is a really nice tip,using compliance matrices within your Quality System.

UK MDR, wowza.

Noticeable things from the consultation and the response from the MHRA, here is the main thing that I think is most interesting from. The MHRA have discussed the timelines for changes to the UK MDR, and they are as follows.

I’ve also put a translation from regulatory talk below each of them 👍

Transitional arrangements for UKCA marked devices.

These would apply to general medical devices and IVDs that hold a valid certification/declaration of conformity to the UKCA standard, before the new regime takes full effect. 

• The government would like to establish a transitional arrangement for these products which will allow, at a minimum, products to be placed on the market until either the certificate expires or for three years after the new regulations take effect (in the case of general medical devices) or five years (in the case of IVDs), whichever is sooner. 

Caveats

• devices that are subject to significant changes in design or intended purpose will be excluded from these provisions 

• all post-market requirements applicable to the new regulatory framework will need to be complied with for all products which benefit from the transitionary arrangements 

Translation

For medical devices and IVDs that hold valid certification or DOC, they will have be able to be placed on the market until the certificate expires, or three years (MDs) or 5 years (IVDs) after the new regulations take effect (whenever is sooner).

Transitional arrangements for CE marked devices

• EU MDR and IVDR - The government intends to introduce the transitional arrangements general medical devices and IVDs that hold a valid certification/declaration of conformity to the CE standard. It is intended that the government will establish a transitionary arrangement for these products which will allow products to continue to be placed on the market until either the certificate expires or for five years after the new regulations take effect, whichever is sooner. This will apply even if the certification/declaration of conformity is dated after the new regulations take effect. Products certified to this standard will be permitted to be placed on the Great Britain market for up to five years from the date on which the new regulatory framework takes effect, with a view to reviewing this provision at the end of the five-year period. 

• EU MDD, IVDD and AIMD - For general medical devices and IVDs that hold a valid certification/declaration of conformity to the CE standard, issued under the EU Medical Devices Directive, the EU Active Implantable Medical Device Directive or the EU in vitro Diagnostic Medical Devices Directive before the regulations take effect. The government would like to establish a transitionary arrangement for these products which will allow, at a minimum, products to be placed on the market until either the certificate expires or for three years (for general medical devices) and five years (for IVDs) after the new regulations take effect, whichever is sooner

Translation

If you have a device that is on the UK market, with a CE Mark to EU MDR/IVDR, you will have from 5 years from 1st July 2023 to utilise the UK MDR (When it is released) or whenever you certificate expires.

If you have EU MDD, IVDD or AIMD, the transition period will be until the certificate expires, or 3 years for general medical devices, or 5 years for IVDs.

🤓 Audit Tips

☀️ Summary

Audits can be complex to try and organise, and present information.

So, anything that can make this simpler, I welcome. The first thing I wanted to share with you was a short opening meeting powerpoint presentation.

Being an auditor is pretty tiring, you’re presented with a huge amount of information over a short space of time.

This little tip makes life a bit easier for them, and always goes down really well when used.

Use an opening meeting powerpoint to describe your organisation and the set up of your QMS, with things such as key staff, the scope, organisation charts etc.,

Here is the template I use if you like, but it’s not rocket science so feel free to make your own -Opening Audit Powerpoint Template

Also, while we’re on audit tips, I thought I’d refer you to an article my friend Monir El Azzouzi from Easymedicaldevice.com done on using a front and back room set up Check out Monir’s great article for more detail - https://www.podcastics.com/podcast/episode/prepare-your-audit-with-a-front-room-back-room-128325/

🌴 Compliance Matrices

✅ Summary

I wanted to give you a little tip here and another template.

Whatever industry you’re in, there is probably more than one standard, regulation or legislation that you’re working to.

I don’t know about you, but I always like to know where I am with regards to conformance.

The main way I do that is using compliance matrices

A compliance matrix (sometimes called a requirements compliance matrix) is a tool you use to cross-reference your current methods of conformance with your chosen requirements (ISO 9001, 13485 or 27001 for example), this then lists exactly where in your QMS (section, page number, etc.) you meet the requirement. This makes things super easy to maintain compliance, but also demonstrate conformance to i.e. linking to a policy, or control for example.

This can also be used for contractual obligations for example, but mostly I use it for standards, legislation or regulations. See template here - Compliance Matrix