The House of Commons Health and Social Care Committee's Brexit Report is released on 21st March 2018 and shows scant consideration of the regulatory cataclysm facing the UK Medical Device Industry. Little over a year to Brexit and no hint of a mechansim to adopt MDR and IVDR into UK Law - indeed with:

the prospect of Britain finding itself in medical device regulatory area of one country seems increasingly likely. Additional regulatory and administrative costscould be penal and many companies will see little alternative than to relocate their EU operations to an EU-27 country and follow the Commission's January 2018 advice.

A USD 9.5Billon industry facing demise through government inaction!

• Notified Body Consistency
• Centralization and Consistency of AIRs
• Improved borderline issue management
• Responsible Person
• Improved transparency
• Improved traceability
• Increased clinical input
• Import Management
• Increased Eurocrats
• Classification and ER Review
• IVDs to come into line

Trumping User Fees

Standards Nightmare

Not only are we still smarting under DG SANCO's rewrite of ISO 14971 to a slavish letter-of-the-law interpretation of the directive, but now ISO TC 210 has accepted DIS 3 so ISO 13485 will not follow the Annex SL format, which is used for all other management system standards including ISO 9001:2015 - when will the regulators stop trying to fiddle standards to suit their needs rather than accept the sound quality philosophy underlying the standards process? This will force many device companies to drop ISO 9001. How sad to see quality principles being compromised by the regulators who claim to value them!