Thoughts ahead of next year’s MDR deadline

Adaptive Life Science caught up with Monir El Azzouzi on some of the latest developments in the Medical Device industry.

To make the puzzle easier for us, Monir is helping us all on the MDR transition journey, so be sure to check out his website for the latest news, courses and insightful podcasts. You can find access to these free resources here; https://easymedicaldevice.com for the blog and https://podcast.easymedicaldevice.com to access the free podcasts.

Monir has spent many successful years working for major players in the Medical Device industry, including Aesculap, Bausch & Lomb and Johnson & Johnson in quality and regulatory focused positions. I caught up with Monir to discuss some of the advances, and challenges with the MDR changes coming next year.

The hot topic of the moment, the MDR deadline coming in May 2020 for Medical Device manufacturers and notified bodies… What is your opinion on the MDR and changes to the framework?

We needed a new change in the regulations, as there hasn’t been one since 1993 except some amendments. The changes in software and artificial intelligence are not regulated under the MDD, and they will be under the MDR. This in itself shows us that we need the change. There have been a number of triggers over the years to suggest a change in the regulations, most notably the impact from the PIP breast implant scandal from 2009, which were sold with unapproved industrial-grade silicone gel.  Events like this accelerated the way the way in which the MDR was created and the new framework developed. It was rolled out quickly, and there was a lot of discussion and urgency. In short, we needed it, but the way it was delivered was not ideal. Now as manufacturers we have to deal with it and manage the transition. The fault is not only on the EU commission for how it was presented, it is also on device manufacturers who lack understanding and acceptance, and now try and ensure compliance too late in the process. We could have a bottleneck at the end, and a higher need for consultants to come in, fix problems and educate the stakeholders. The candidate market in the MDR space is dry and it could be a struggle to find the most qualified person to take on the challenge now.

Could the MDR deadline be extended, due to the shortage in designated notified bodies, and lack of urgency from some manufacturers?

I recently spoke with Erik Vollebregt from Axon Lawyers about this topic who said it is difficult for the EU commission to extend the deadline. We would basically need to start the process from scratch. There have been talks to use the strategy that is used for MDSAP (the single audit programme – USA, Canada, Brazil, Japan, Australia) If there are not enough notified bodies (NB’s) to complete the new certifications; currently at 5, 16 anticipated by EOY. Then perhaps there could be a procedure for showing an application for certification under MDR, even if it is not fully compliant by the deadline. The bottleneck that I mention is not only down to manufacturers certifying under the MDRs late; a lot of manufacturers are ready and waiting for their Notified body to be approved. Even then, some NB’s may still choose not to go through the MDR designation process, leaving manufacturers scrambling for a new Notified body that also has capacity to accept new customers. Before we had 80 notified bodies, then 70 and with the MDR we are still only at 5. 80 NBs to 5 is alarming. 

Who is having the biggest challenge? Smaller manufacturers or global players?

Smaller manufacturers, if they are coming late to the game. It is a question of resources; the global companies should be well underway in their transition. Like small notified bodies, it is the smaller companies that could struggle the most. If you have not started the MDR transition, you are in denial!

The British have a great saying, which helps in this scenario:

Stop thinking it will be extended, that a miracle will happen, and start acting. It should also not be about surviving, it is about beating the competition – and your products will go to market quicker. It depends on whether the organisation is focused on sales or compliance, because although profit margins may be strong now, from May 2020 your products could be unsellable on the market. Think long term – that’s my advice.

Is the designation too tough for a Notified body? Is that part of the problem?

I think it’s appropriate and it harmonizes the standard across manufacturers. With the new requirements, there is a search to ensure that the Notified body chosen is trusted and impartial. Now with the MDR, the NB’s are heavily audited – so if they make the wrong call, they lose their certificate. Officially, there is also no longer a consultancy service from a Notified body under the MDR – they are just there to rate your performance and compliance.  It is tougher to be a Notified body under the new regulations, however for manufacturers you will now have an auditor who knows your devices (ie cardiovascular) so, approval is genuine without grey areas. You will have a genuine specialist monitoring your activities – this is good for customers too; having faith in the devices they use, and that they are properly regulated.

There seems to be some concerns over the labelling requirements for the MDR transition – do you have any guidance on this for manufacturers?

The UDI requirements could be a challenge – as this barcode must be on every device or packaging. The struggle can be if there is a large portfolio of products, not so much if there are a small number of specialist devices, so I imagine it is the larger manufacturers who would do well to hire a labelling specialist. This does not have to be a strategic person, but someone to execute the changes. At the beginning of the MDR transition, we said look at your whole portfolio, and get rid of waste. If you only sell 3 units per year of a particular device, is the investment in the MDR change worth it? No – it should be discontinued. EIFU (electronic instructions for use) and digitalization is making life easier, and the UDI is more of a space finding activity, nothing too technical!

Consultancies vs In-house – What’s the best strategy?

It really depends on the company. For big companies, I would always recommend having a consultant come in to understand the problem, fix it and leave. For smaller manufacturers, they could need a consultant due to lack of resources and headcount, but also, they will need a long-term conrtractor as regulatory compliance is a journey and has long term requirements. There also must be a PRRC (person responsible for regulatory compliance) – either a consultant, or in-house. Under the MDD, a sales rep could be the PRRC but now it must be a qualified person. My advice to smaller manufacturers would be to assess your level of need, portfolio of products and weigh up the balance on the cost of a highly qualified consultant, vs building an in-house team where all the value and understanding is retained in the business and team.