17 August 2016
5:30-8:30 pm
Johnson & Johnson
Fremont, CA
Join your regulatory colleagues from across the San Francisco Bay area for an evening of networking and an expert presentation on the changes to MEDDEV 2.7.1. This meeting is sponsored by the RAPS San Francisco Bay Area Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory professionals. A light meal will be available and attendees may claim two RAC recertification credits.
A new revision of MEDDEV 2.7.1 represents a complete re-write, with many new appendices and much new guidance. This revision will lead to clinical investigations being conducted more frequently for CE Marking (probably of larger size than before) and notified bodies will be looking more closely at how all the essential requirements are met, including those with regard to usability. The CER reports themselves will need to be updated more frequently, written and reviewed by more highly qualified evaluators, and more closely integrated with the various stages of the product lifecycle. With the publication of this revision, and no transition period typically being provided for the MEDDEVs, it would be in the manufacturers best interests to start discussing with their notified bodies how they will start implementing these new requirements and to start performing their gap assessments and resource needs-assessments now. Urgency on gap assessments is warranted, as manufacturers will be expected to budget for additional clinical data asap; hence the assessment will need to feed into the budget plans for next year if clinical studies might need to be initiated in 2017.
Some questions that will be answered during this presentation include:
- What is the European MEDDEV 2.7.1 Rev 4 for Clinical Evaluation?
- What are some of the most significant changes?
- When does this go into force?
- How does this align with the changes to the Medical Device Directive (MDD)?
- I’ve heard it’s demonstrating “equivalence” will now be harder, but in what ways?
- How often must I update my CERs now and what qualifications must the evaluators have?
- How should I prepare for the increased notified body scrutiny in this area?
- Do I just need to write a CER for CE Marking? If not, when else do I need to do this and with what focus?
- How do I perform a clinical literature review to meet the new expectations?
A valid photo identification will be required to enter the premises. Participants will not be able to gain access without a photo ID.
Date/Time:
Wednesday, 17 August 2016
5:30–6:30 pm Registration Check-in, Networking and Dinner
6:30–7:15 pm Speaker Presentation
7:15–7:30 pm Break
7:30–8:00 pm Workshop and Case Study Activity for Attendees
8:00–8:30 pm Question/Answer Session
Location:
Johnson & Johnson
6500 Paseo Padre Parkway
Fremont, CA 94555
Get directions online, or call +1 510 248 2500
Registration:
Advance Registration (prior to 11 August):
RAPS Members: $25 Nonmembers: $35
Registration (on or after 11 August):
RAPS Members: $35 Nonmembers: $45
» Registration Form (PDF) - for registration by mail or fax.
You can also register by calling +1 301 770 2920 ext. 200.
Featured Speaker:
Keith More, PhD, vice president, regulatory compliance, Qserve Group US Inc.
Local Contact:
Shweta Kaushik, PhD, RAC, registraton chair, RAPS San Francisco Bay Area Chapter
RAPS Contact:
Wesley Carr, senior manager, chapter and volunteer relations, RAPS, +1 301 770 2920