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Self-Care Devices Will Need New UKCA Mark Post-Brexit

 
• By Tom Gallen

Self-care medical devices sold in Great Britain post-Brexit will require a new UKCA certification mark, which importantly will not be recognized in the EU, EEA or Northern Ireland, requiring manufacturers to navigate two separate regulatory systems. 

Brexit
• Source: Shutterstock

Self-care medical devices will have to be registered in the UK and follow a new certification process once the Brexit transition period comes to an end, according to new guidance from the Medicines and Healthcare Products Regulatory Agency.

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More from United Kingdom

Over The Counter: Brands, Brexit And New Self-Care Business Models, With PAGB’s Michelle Riddalls

 
• By David Ridley

HBW Insight catches up with UK OTC industry association CEO Michelle Riddalls to talk about digital self-care and the unrealized promise of Brexit - part 2.

Clasado Divests Bimuno Prebiotic Consumer Brand To UK’s Eleat

 
• By David Ridley

Eleat's acquisition encompasses Clasado's Bimuno finished supplement product line and customer base, but not its Bimuno GOS proprietary galactooligosaccharide prebiotic ingredient.

‘The Only Certainty Is Uncertainty’ In The UK’s Consumer Health Market

 
• By David Ridley

While uncertainty might reign in the UK consumer health market - which grew by by 8% to £4.1bn ($5.3bn) in 2024 - “opportunity is everywhere” according to NielsenIQ health and beauty insights manager Alex Heffernan.

Over The Counter: Evolving The UK Consumer Health Industry, With PAGB’s Michelle Riddalls

 
• By David Ridley

HBW Insight catches up with PAGB CEO Michelle Riddalls to chat about the association's new five year plan. Riddalls also reflects on the successes of the last five years, including relaunching the UK Reclassification Alliance, which has published a list of Rx-to-OTC switches the government would like to see applications for. Part one of two.

More from Europe

French Agency Proposes Effective EU Ban On CBD In Foods And Cosmetics

 
• By David Ridley

France's food safety regulator ANSES is proposing a reproductive toxicity category 1B classification for CBD under the EU's CLP regulation, which would mean an effective ban on CBD in cosmetics and foods. However, French hemp industry association UIVEC hopes that new evidence coming out of a European Commission review will put the issue to bed before it gets that far.

Clasado Divests Bimuno Prebiotic Consumer Brand To UK’s Eleat

 
• By David Ridley

Eleat's acquisition encompasses Clasado's Bimuno finished supplement product line and customer base, but not its Bimuno GOS proprietary galactooligosaccharide prebiotic ingredient.

EU Parliament Agrees To Postpone Due Diligence And Sustainability Reporting Rules

 
• By David Ridley

Speaking at a recent AESGP webinar, sustainability expert Onur Durmus called the the European Commission’s “Omnibus” proposals - designed to simplify ESG reporting rules and recently supported by EU Parliament - a “positive development” for the European consumer health industry.