3 things to consider on your medical device regulatory strategy – post Brexit

Do you know how rapid regulatory changes and issues like Brexit have affected your current regulatory plans?  

Are all your current or intended markets covered by the same regulations now or have some of your deadlines changed? 

Are you staying up-to-date with the latest Quality and Regulatory Affairs information? Do you know where to find the regulatory information you need? 

Challenges for medical device manufacturers 

A lot of the businesses we speak to know exactly where they want to be, but they are finding the road map has altered significantly over the last year. It’s daunting enough to be a new medical device company attempting to navigate all the terminology and classifications. But even some of our well-seasoned clients are stepping back to consider how recent changes could impact their business if they don’t get up to speed in all the markets they want to sell their devices in. Some who were on track for MDR covering the EU, suddenly now need a UKCA approach as well if they want to stay in both markets. Others are now considering the US as their preferred first market to enter.  

Some medical device companies are finding it a challenge to ensure they are entirely up-to-date with the differing deadlines, developments and changes to regulations over recent years.

And with the pandemic affecting so many businesses, some regulatory plans have gone on the backburner until the economic situation improves.  But this means time to prepare for the fast-approaching deadlines is shrinking. And we are urging clients to consider their timelines as early as possible.  

Project timeframe 

As deadlines approach, many businesses could find they’ve left things too late.  This could result in a lot of stress and frustration, especially when they also need to consider that many notified bodies are overrun with projects with delays of up to 12 months for a slot! Many notified bodies need most of your documentation just to consider taking your device on. Meaning there is a lot to be done. 

We want medical device clients to be fully aware of such issues; the need to focus on regulatory planning, slotting in activity to produce documentation. And keeping an eye on their budget too.  

An expert can work quickly  

At IMed, our expert consultants are aware of all the deadlines and the right questions to ask. We can look at your documents very early on. You may need us for a gap analysis to help you catch up, giving you templates to work from. Or if time or resource is an issue, one of our experienced consultants can do the work for you against planned slots and milestones. Even if it turns out you are all set – it’s worth knowing that your documents are ready. Better that than joining the back of a bottlenecked regulatory queue in Spring 2021 for MDR, Spring 2022 for IVDR or early 2023 for UKCA.  

We stay up-to-date with all the latest information across multiple markets.  With our significant expertise, we can help you as much or as little as you need. Supporting you through all stages of your device lifecycle; from early device design, regulatory planning and obstacles, the development of your product and ultimately the releasing your product to market.  

So, let’s talk and avoid any last-minute stress. Contact IMed now via Al Mills, our Business Development Director, on +44 (0)1295 724286 or email alison@imedconsultancy.com to arrange a brief regulatory deadline health check for your business.

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