Make your mark
Olivia Friett shares thoughts on the current and ongoing regulations in the US, UK and EU.
There’s always something new to learn about in the medical plastics sector, in fact trying to keep up with regulatory updates has become a common struggle.
As someone who is relatively new to the sector, I’m constantly finding myself learning new things about regulations and having to search for updates and further information on a weekly basis – but it seems regardless of how long you’ve been in the field, everyone is in the same boat.
The government has put in legislation that amends the UK MDR to extend the acceptance of CE marked medical devices on the market. This means devices that are compliant with EU MDR or EU IVDR can be on the GB market until 30th June 2030. This is not to be confused with the indefinite recognition of the CE mark announced by the government for other sectors – so medical devices are indeed getting some special treatment. Whether it’s the right treatment remains to be seen.
In the past few months, I’ve had the privilege of being invited to some incredible talks and shows and undoubtedly, “regulation” was the word on everyone’s lips.
At Med-Tech Innovation Expo, there were several talks on regulation each day.
There was a live MedTalk Podcast on the subject “The Latest in the Med-Tech Regulatory Landscape”, which featured Professor Laurie Rowe, founder and CEO of Red MedTech, Fiona Maini, principal global compliance and strategy manager, Dassault Systemes and Laura Friedl-Hurst, principal consultant and managing director, LFH Regulatory.
The topics covered included ‘The latest developments surrounding UK requirements’, ‘How recent fast-track approvals from EU, US and Japan may affect the UK’ and ‘International regulations: The effect on UK innovators and the effect on overseas innovators coming to the UK’.
On the second day, Dr Nicola Thorn, CEO, AND Technology Research, discussed how to navigate regulatory hurdles for software/technology-based products. Thorn described how software products fit, how developers can navigate the challenge around regulatory submission, and how AND Technology can help.
Regulations was also at the forefront of the HealthTech Integrates conference focused on technology, diagnostics, devices, and therapeutics.
James Fry, partner and head of life sciences, Mills & Reeve facilitated a session with panellists from iMed Consultancy, British Standards Institution (BSI), ORCHA and Element Materials Testing. By having panellists from different departments in the sector, the audience were able to capture a gauge on if regulation is keeping pace with innovation.
Additionally, a talk on navigating the regulatory pathway and how to prepare the regulatory strategy to enable a rapid route to market and select the right regulatory pathway was facilitated by Hugh Harvey, managing director of Hardian Health, and again the panellists were from different departments and at different levels of regulation in the sector – BSI, Prosoma, Decode X, Mills & Reeve and 52 North Health, meaning the audience could have a clearer picture and the best advice on which route to take.
Forgive the list but what I’m getting at is regulation discussions are everywhere in the industry, but with talks of transition, amendments and still not a clear picture of how the landscape will end up, especially in the UK, even those who know a lot feel like they know little.
Picking the right regulatory pathway is probably the biggest choice companies are having to make – is it worth paying to be UKCA marked? Do you stick to the bigger markets such as EU and US? Will choosing incorrectly affect the company? Or the UK? The lack of clarity makes things so uncertain.