August 2023 – The MDR is Dead!

Did that headline catch your attention?

I thought so. Well is the MDR indeed dead or is it even alive? Since February 2023 there has
been a serious drop in MDR activity, while many MDR gurus are still organising conferences
discussing the regulations with a desperate attempt to keep industry engaged, but much of the Medical Devices industry is desperately trying to disengage from the conversation. Others have turned towards US FDA and UK markets where there is more certainty to commercial markets.

There have been some key events and dates which have caused a turning point in the industry:

• PIP Scandal with Breast Implants – March 2010
• EU MDR 2017/745 Draft released – 2014
• EU MDR 2017/745 official release with key dates for transition – 2017
• Global Pandemic shifts DOA Soft date to 26 May 2021 and not 2020
• Major Industry pushback on 26 May 2024 dates of DOA Hard date for transition results in 4-5 year extensions to certificates (given conditions) as of Jan 2023

The release of the EU MDR 2017/745 as well as EU IVDR 2017/746 for In vitro Diagnostics was a
significant milestone in raising the bar for Medical Device patient safety, remembering that these
regulations were released after a spate of patient traumatic experiences from poorly tested Medical Devices as well as fatalities which called for a more robust legal process to commercialise Medical Devices in Europe.

Since the extension of the MDR transition from the old MDD, it is key to note:

1. As of Oct 2022 – 8120 Applications were made with only 1990 certificates issued (almost 25% of applications certified), however this had risen from 1840 Applications in February 2021 with only 224 certificates issued (around 12% applications certified).
2. The applications increased in March 2023 to 11418 but still the certificates issued were around 25% of the applications around 2951
3. In total there are around 22,376 certificates issued under the MDD which are due to expire in May 2024
4. At this rate around 7000 MDR certificates may be issued by May 2024 with existing Notified Bodies (we note that the number of Notified Bodies is increasing, slowly)

This means that industry has largely backed off with transition to the regulations due to the extension period granted. However, only for the timer to start again towards 2027 and 2028 (the
end of the granted extension), on average if the backlog is 9 months for notified bodies and around 10% of the 22,746 has been granted, this means that the remain 20,000 certificates at this rate.

In September 2021 there were only 502 certificates issued compared to 1990 in Oct 2022, meaning an additional 1400 or so certificates in one year, at the rate of 1400 certificates a year the backlog of certificates will not be cleared by 2027/ 28 and we will need approximately 14 years to clear this!, in order to clear the backlog Notified Bodies need to work 3.5 times quicker or we need 3.5 times more Notified Bodies to the current 39 Notified Bodies designated to issue certificates. Please note that the extension to the MDR wasn’t given specifically for manufacturers, it was actually to allow notified bodies more time. This also means that manufacturers should not have stepped off the gas, so what’s the inevitability?

1. The EU commission will extend the dates again in 2027/2028?
2. The EU commission will kill the MDR altogether?
3. The EU commission will designate more notified bodies?
4. Notified Bodies are hiring more Technical reviewers to work through the workload

There are many who have suggested the EU MDR is harming medical device innovation due to the higher requirements for CE Marking. There are now also more guidance and best practise
documents being released to assist industry to align themselves to the EU MDR, but why hasn’t the EU MDR been embraced?

• Costs of Regulatory – the transition can cost is thousands per technical file, with applications to notified bodies and fees for audits and then maintenance of the more “demanding” regulation in areas such as Clinical Data, Post Market Surveillance and Vigilance, and change in classifications which may have resulted in self-declared CE certificates to full notified body audit requirements.
• The uncertainty of certification
• The time taken for certification
• Demanding resources needed for compliance over development.

As of April 2022 (From MedTech Europe)

• MDR certificates have not been issued yet for 85% of the >500,000 devices previously certified under the MDD or AIMDD
• Larger companies are actively filing under MDR. Review is still ongoing for 70% of submitted industry applications
• The time-to-certification with MDR-designated Notified Bodies is taking 13-18 months on average >50% of respondents plan portfolio reductions. 33% of these companies’ medical devices are currently planned for discontinuation
• At least 15 % and up to 30% of Small and Medium Enterprises (SMEs) still have no access to an MDR-designated Notified Body
• New devices and class III devices were more likely to lead to longer certification timescales
• 70% (1,720 out of 2,446 total) of submitted applications for Quality Management System (QMS) and Technical File (TF) certificates are still under review by the Notified Bodies
• 31% or 753 out of the 2,446 total submitted applications have resulted in the issuance of a certificate

Supply and Demand of Skilled Resource

Since the release of the EU MDR in 2017 the number of resources trained to deal with the transition was in significant shortage, there was a multitude of ideas to deal with this including training fresh graduates. Some of the recruitment companies can comment better on this but there was also a significant spike of contractors shifting from permanent and to deal with the surge of work the number of agencies also multiplied. Fast forward to present day July 2023 and the market has slowed since February 2023 and several contractors have gone back into permanent work, and several agencies will need to recruit for projects aside from the EU MDR work. An indication of the number of consultants as of 2023 in the regulatory field was very visible at the recent Med Tech Expo in NEC Birmingham, where in recent years there were only 2 – 3 Regulatory services being exhibited, at the June 2023 Med Tech Expo there were around 13 Regulatory services exhibiting!

So is the cake bigger? If so then welcome to more consultants, the cake has in fact shrank. So does this mean there is no work for Quality & Regulatory services? No!, industry still needs:

• FDA submissions – US is the biggest global player for Medical Devices and takes up more than 50% of the market share while EU is only 25% (estimated), more new businesses are now hitting the US market as opposed to EU due to the above issues.
• Digital Healthcare (AI and ML) – is on massive rise and so are exhibitions and events in this related area.
• UKCA – while the UK government is still firming up the regulations to be reviewed Jul 2025, there is a window of opportunity to register devices under the UK MDR 2002 which especially for Class I devices such as Software create great gains otherwise in EU the same device is Class IIa under the EU MDR.

This has been defined as a scenario in which the cost of everyday essentials like energy and food is rising much faster than average household incomes, it is no doubt that companies are cutting costs where possible due to ongoing costs and Quality & Regulatory costs have always been subject to cost-cutting even when not in a recession.

So is the MDR dead?

The EU commission need to evaluate the success of the implementation of the MDR and IVDR
since its arrival in 2017 and how much longer the market will take to recertify all those MDD
certificates without killing innovation, because if the MDR isn’t dead then it certainly is killing
innovation in Europe. Therefore for Start Ups it is has become more challenging to launch their
devices in Europe, industry must keep going with their transition but for start-ups they may wish
to consider an alternative market, considering US is a brilliant option.

Simplimedica is offering training in General Regulations, EU MDR Regulations as well as very
competitive packages to get your devices commercialised.