Blog focus BSI’s 2^nd in a series of White Papers for Medical Device & IVD industries, on Generating clinical evaluation reports

White Paper on Generating clinical evaluation reports

This white paper is on “Generating clinical evaluation reports – A guide to effectively analysing medical device safety and performance” and is focused on “…guidance on how to satisfy important regulatory requirements e.g. the concept of equivalence and post-market clinical follow-up (PMCF).”  It is written by Dr Hassan Achakri, PhD, Director, International Clinical Affairs, Zimmer GmbH; Peter Fennema, Director, AMR Advanced Medical Research; and Dr Itoro Udofia, PhD, Orthopaedic & Dental Team Leader, BSI .

I have the distinct pleasure and honor of assisting BSI review this white paper as a member of the BSI Medical Devices White Paper Advisory Panel for this series of white papers.

White Paper Series and Future Topics to Come

BSI says of this series that “Throughout the year, we are going to be producing a series of medical devices white papers. These will keep you up to date with regulations, developments and help you prepare for changes within your industry.”

The additional white papers in the series will be on:

• The digital patient
• What medical device manufactures need to know about FDA’s Unique Device Identification Final Rule
• Post-market surveillance
• Usability engineering

You can sign-up for the whole series of white papers too (further down the webpage on BSI’s website). 

If you need help with your EU CE Mark Medical Device Directive or IVD Directive Technical Files or Design Dossiers, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

BSI recently updated the white paper on Proposed EU Regulations for Medical Devices & IVD’s to reflect the latest EU vote in early April, enabling the commission to move forward with the legislation.

Refer to the previous blog post on BSI White Paper on Proposed EU Regulations for Medical Devices & IVD’s for additional details about the white paper and the Series of white papers.

You can sign-up for the whole series of white papers too (further down the webpage on BSI’s website). 

If you need help with your EU CE Mark Medical Device Directive or IVD Directive Technical Files or Design Dossiers, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

9 April 2014 – Today marks the beginning of a series of white papers that BSI has just released.  

White Paper on Proposed EU Regulations

This initial white paper is on the “The proposed EU regulations for medical and in vitro diagnostic devices” and is focused on “An overview of the likely outcomes and consequences for the market”.  It is written by some of the best authorities in the business, on this subject, Gert Bos of BSI Head of Regulatory and Clinical Affairs and Erik Vollebregt Partner at Axon Lawyers, that I personally know and trust. I have the distinct pleasure and honor of assisting BSI review this white paper as a member of the BSI Medical Devices White Paper Advisory Panel for this series of white papers.  

BSI states that this white paper reviews “the proposals for the new medical devices (MDR) and IVD regulations (IVDR) will provide a new regulatory framework for medical devices in the EU for the coming decades. Although crucial elements of the regulations are still subject to political debate, one thing is clear – the regulations will cause important changes for you. Use this white paper to find out how to prepare for these changes.”

White Paper Series and Future Topics to Come

BSI says of this series that “Throughout the year, we are going to be producing a series of medical devices white papers. These will keep you up to date with regulations, developments and help you prepare for changes within your industry.

The additional white papers in the series will be on:

• Generating clinical evaluation reports: A guide to effectively analyzing medical device safety and performance
• The digital patient
• What medical device manufactures need to know about FDA’s Unique Device Identification Final Rule
• Post-market surveillance
• Usability engineering

You can sign-up for the whole series of white papers too (further down the webpage on BSI’s website). 

If you need help with your EU CE Mark Medical Device Directive or IVD Directive Technical Files or Design Dossiers, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

If you are reading this post my guess is you already know the proposed MDD regulations are contentious and that there is some major changes proposed some good and some not so good. 

The later occurred a couple weeks ago when the Rapporteur Mrs. Roth-Behrendt proposed in a draft report for the MDD regulations.  As Eucomed states “The draft report is a step backward for patients, healthcare systems and Europe.”  The reason is the report calls for “a shift towards a centralised pre-market authorisation system which if carried through to the final legal text will confront patient in Europe with unnecessary delays of lifesaving medical devices reaching them without improving safety.”  The system would create a “enormous bureaucratic system with no benefits.”   Note, this is not a final report so there is a ways to go before we know if this will be finalized as is or modified. 

To get more information and perspective from these organizations please read on the posts and articles: Erik Vollebregt excellent article on the draft report detailing what the changes are; a Guest blog post on Erik Vollebregt medicaldeviceslegal website titled “no enhanced patient safety resulting from rapporteur Roth-Behrendt’s proposal”; Eucomed’s position and understanding of the Rapporteur ‘s draft report; a blog post by the CEO of MedTech Europe, EDMA, & Eucomed in regard to draft report for the MDD; MedTech Europe story on “European Parliament’s ENVI Committee releases draft reports on MDD and IVDD; and Where the EU system for medical devices is and needs to go.

We hope these articles help you understand where the process stands and help you form your own opinions.  From there where you go is up to you but know we will keep sending you updates on this process as we find relevant information to pass on as this process is critical to the survival of the European Medical Device Market.