MeddiQuest Limited
Regulatory Affairs Management
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Medical Device Regulation

The Medical Device Regulations (EU) 2017/745 and 746 have now been published will become numbers to fear!- no mean political achievement, but alas there are plenty of flaws in a regulation of disproportionate complexity to the issues it attempts to resolve.
The regulation is still hardware-centric and the little language in the draft addressing software has been removed - overall this means that the regulation is better suited to the medical devices of the last century than the innovative new products of the next decades.
The issues around reuse of SUDs has been fudged to allow member states to do anything they like and the tightening of controls seems to do more and the wholesale reclassification of ingested devices into the highest category irrespective of risk is likely to bring the new regulation into disrepute.
See Neil's Blog.
Select Committee Brexit Report
 

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:

  • adopting implenting and delegated acts ruled out in the PM's Florence speech
  • the political impossibility of adopting to two new EU regulations meer weeks after leaving the EU
  • and an increasingly protectionist US adminstration unlikely to do a trade deal without acceptance of US regulatory primacy
  • 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!

    See MeddiQuest's Press Release

    RAPS on-line university and RAC certification are major pillars of our profession
     
    Neil lectures on the TOPRA MSc Courses in Medical Technologies Regulatory Affairs.
    MeddiQuest's National and International Strategic Partners
     
    MeddiQuest's EU Authorized Representative Service
    Armstrong: Comments will change the future

    Key Proposals
    • 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

    The Trump Administration is proposing to double User Fee receipts from USD 1.2 to 2.4 Billion, on average doubling drug and device user fees. So if you were thinking of a complex US Submission, getting it in quickly could save you thousands!

    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! 

    Come and talk to use about your quality and risk issues

    MeddiQuest Team Building
    The MeddiTigers became MuddiTigers to take part in the 2015 Yorkshire Tough Mudder as our annual team building exercise. What could be more fun than being frozen, wet, electrocuted and running a ten mile assult course? Maybe something easier like a triathlon next year! Hey, special credit to Ivan, because even though he left us a few years ago, he still came back ... he will know better next time!
    MuddiTigers
     
    MeddiQuest is a member of the IET Healthcare Technologies Network.
     
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    Uploaded March 20, 2005 - Last updated March 21, 2018
    MeddiQuest Limited: Incorporated in England under number 4226188 at Peterscourt PE1 1SA UK