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A new year ahead, the start of the ‘roaring twenties’ in devices...

Gert W. Bos, PhD, Fraps

One hundred and forty days left for the official one-year extended transition period of the EU MDR. Recent news is ‘not good’, as no additional guidance has been published for over quit some weeks now, and the number of notified bodies designated under MDR (and IVDR in the same way) has been reduced due to the Brexit transition period being closed without a deal in the realm of medical devices.

By now it is becoming clear to all that the meagre deal that was agreed on the departure is not covering many of the goods, and that is valid for the devices as well. That means that we will all need to move ahead with our preparations, as the continued acceptance in the UK for the CE mark on our products will be phased out in time. Instead, a new UKCA mark will need to be added, which at this stage may be achieved by one of three UK bodies (BSI, UL, SGS), with only BSI having the full scope. Scope of the UK bodies will also cover the NI protocol for the special agreements in Northern Ireland.

It also means that all manufacturers from outside of the UK will need to assign a local representative, the UK rep. That can be your local office, perhaps your importer into the UK, or if you want to retain full control, an independent third party. Duties of such UK rep include registering your devices into the MHRA database following a document check, acting as contact person to MHRA enquiries, and support corrective actions as needed. It would also include funneling to the manufacturer any complaints and reports from healthcare professionals, patients and users about suspected incidents related to the devices/IVD’s registered it receives.

Anyway, back to the MDR. Where many must take back control, as the pandemic has delayed most MDR programs.

As we progress towards compliance and the number of issued certificates are steadily rising, there is an effect of community learning to be seen. Notified bodies are getting clearer on what they want to see to conclude on compliance, and manufacturers are learning from their first dossier’s mistakes and deficiencies. Overall, it appears that numbers of deficiencies, and timelines to close them out, are slowly going down. Key areas of concern remain clinical evaluation, risk management and state of art. Depending on the type of products, it may include toxicity and biocompatibility, or for example usability details and single fault conditions.

On the audit front, we still are in limbo as no fully remote initial MDR audit will be accepted by the EU legislator at this stage. Despite the heavy push from industry and the notified body forum alike. But notified bodies are preparing for rapid clearance once global travel restrictions will start to be lifted, by doing as much as possible already upfront in remote audits. Final elements of confirmation can then be swiftly completed during the final on-site part of the audit.

We also see the start of the late adopters moving towards the MDR programs. Having waited until the first hurdles have been taken, companies are looking for a smoother and faster ride into the MDR, learning from all the challenges and developments that have been made in the past few years by the early adapters. From blogs, whitepapers, and from using consultants or hiring staff that already experienced MDR programs in their previous jobs, they will save some time indeed, as the implementation of the requirements might be more focused and efficient. Still, the overall burden of additional work is huge, both for the initial phase to get the MDR certificate(s), as well as in the maintenance phase, where strong PMS and PMCF requirements are at the forefront.

In that space, specifically on PMCF, we see a rapid change occurring in our CRO. Where some PMCF clinical studies cannot be prevented, especially for new and innovative devices, the number of companies engaging in PMCF surveys instead of trials is rapidly going up. Of course, such surveys should be well protocolized for the data to be submissible to the notified bodies. But also there we see that debates with notified bodies are getting clearer, and the level of expectations from the notified bodies in this aspect is getting clearer. Again, the community learning effect helps both industry and notified bodies.

Another change that is starting to close in is the realization that all manufacturers must assign their PRRC before the start of the grace period in May this year. Many are following dedicated training to prepare for such a role; other companies are looking to outsource as they might not have sufficiently qualified staff available for the additional level of work.

Meanwhile, the clock is ticking. A hundred and forty days left, and then we move into the spare time, depending on the dates specified on your current MDD or AIMD certificates. The message to industry is getting clearer. Get your act together and come as close to MDR compliance by 25 May 2021 as you can, to smoothly meet the rapidly changing demands from your notified body. With the new year ahead of us, it is time for full speed ahead.

If you need any support in UK Rephired PRRC or in setting up and conducting a PMCF survey, you know where to find us.

Wishing you a speedy journey to MDR compliance!

Gert

Note: Qserve is offering UK rep service to our customers and therefore Qserve’s office in London is officially listed with MHRA as UK Rep and has access to the MHRA database to register manufacturers medical devices and IVD’s. Part of the responsibilities as UK Rep is to have access to and ensure the technical documentation is appropriate. Read more on the advantages of using Qserve as independent UK Rep, the process, the timelines, what Qserve UK Rep needs from manufacturers, and the next steps to secure placing medical devices and IVD’s on the market in Great Britain here.


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