This article focuses on BSI’s new White Paper Series for the Medical Devices & IVD’s industries, First one on the EU Proposed Regulations
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 , or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).