L@B Brief - October 2022
31 October 2022
Hello again,
IT’S SURPRISING, given all the turmoil in the UK, to see the Europeans getting themselves into trouble of their own making for a change. The farrago over the change from the Medical Device Directive to the Medical Device Regulations looks set to have a negative effect on sales of medical devices into the EU with huge hold ups in getting equipment certified in order to meet the requirements of the new regulations.
It’s a lawyers’ charter of course with manufacturers desperate to keep selling and customers relying on the devices desperate to buy. Only a few limited exemptions in a few territories are available to them and the situation has all the potential to be even worse for IVDs - albeit as a slightly longer term car crash.
At least in the UK we are taking a pragmatic approach and delaying implementation until we can get products through the hoops. (see Medical Device Regulations story below). If there’s an action to take as a result of this, it’s to find yourself a conformity assessment body now, be nice to them, and never ever let them go!
Toodle pip!
Jacqueline
To download a PDF of October's L@b Brief, click here
To download October's Standards Bulletin, click here.
In this issue
Ben Goldacre to speak at GAMBICA conference in March 2023... MDR implementation delayed... Rolling blackouts – how should you prepare?... Innovate UK updates its medicines manufacturing support... Economic Crime & Corporate Transparency Bill will mean more checking at Companies House... Government U-turns on IR35 repeal... Market access and knowledge are key issues for GAMBICA’s biotech members... McKinsey hails Europes’ future in biotech... Launchpads to deliver local growth through innovation support... £14 million awarded to smarten factories... Can UKCA compliance be your competitive advantage?... Opportunity to raise your profile at chemical laboratory exhibition... Medtech incubator launches in West Midlands... LADS programme still on track... Upcoming GAMBICA events... Events... Export Partners press new Minister on trade show access programme... Three Quebec hospitals to expand... Danish HQ of Ferring Pharmaceuticals opens... Seqera Labs secures €22 million to power innovation in healthcare and life sciences... Hong Kong not doing enough to attract bio-tech... Food and Drug Administration issues guide to avoiding drug shortages... Wake-up call on trade finance fraud... Drinks firm fined £30K for breaking sanctions... Zero-emission transport focus of new UCL-HORIBA partnership at UCL East... Med imaging company fined for workers’ radiation exposure... Autoclave manufacturer and service specialist, ESTS (GB) Ltd, joins GAMBICA