New medical device regulations: getting
certified in time

There were a couple of things that hit me as I entered the TOPRA annual symposium in Stockholm on a crisp October morning. Firstly, how busy it was and secondly, how well run and interesting it was.

I attended the symposium for the medical device sessions, but the event also covered human medicine, veterinary medicines and professional development for regulatory affairs professionals.


There’s a lot of work to be done in terms of updates to the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) – both by the regulators and the many companies affected by the changes. The regulations are written and approved but there are a whole host of supporting documents, such as guidance and definitions that are still being drafted.

We all need to predict and plan for existing CE-marked devices and those currently in development.

All medical devices will need to be recertified against the new regulations by May 2020 (IVDs by 2022), but the areas with the most change are the IVDs and combination products. All IVDs are to be reclassified under a much stricter system, needing a Notified Body where they could self-certify before the regulation takes effect in 2022.

The combination product changes in the MDR need more justification and evidence than before, with the addition of some rules.

When you throw Brexit into the mix with the new regulation, there’s change in all areas and no one is quite sure how or where it will end up. But, there’s no time to sit back and wait to see where it lands; we all need to predict and plan for existing CE-marked devices and those currently in development.

If you haven’t already started talks with a Notified Body, I suggest you do; it will get your company on the books and give you an understanding of the timescales for the approvals process. There won’t be any shortcuts and you may be surprised how long it will take. Some Notified Bodies aren’t taking on new clients and others have quoted cut-off times for resubmitting existing products that are well in advance of the May 2020 end of transition.

Get planning and actioning for the changes now and let’s hope we don’t lose too many devices along the way.

Tracey is responsible for running multidisciplinary medical device projects and delivering projects to planned budgets and timelines. With over 20 years’ experience in the medical device field, Tracey has worked on diagnostic, surgical and drug delivery products.

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