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6 min reading time
“Notified Bodies (NBs) are getting hit with a crush of work so great that you’re lucky to get a callback,” says Medical Devices Group Advisory Board member Rob Packard.
NEW WORK: The European Parliament and EU Council are expected to approve the new EU Medical Device Regulation (MDR) and the IVD Regulation in January 2017. The MDR transition period is 3 years and every existing certificate will expire 4 years from the date the new regs are approved. That gives manufacturers 3-4 years to be 100% in compliance.
NEW CUSTOMERS: Most standalone software products and 60% of IVD products will require NBs for the first time. Spinal companies in particular will be hit hard by the reclassification of products from a Class IIb to Class III devices.
FEWER NOTIFIED BODIES: Competent Authorities fire NBs they believe are unqualified. In the past 5 years, there are 25% fewer NBs with a likely 35% reduction in the next 18 months as NBs are evaluated under the new regulations.
THE MDSAP 13: There are only 13 recognized registrars for the Medical Device Single Audit Program (MDSAP) program: http://bit.ly/TheMDSAP13. Health Canada will implement MDSAP and the compliance deadline is January 1, 2019. Seven (7) of the auditing organizations are not available to conduct audits. Two more of the remaining six auditing organizations have not successfully completed the criteria for the pilot assessment to include witnessed audits. Then there were four: BSI, Intertek, LNE/GMED, and TUV SUD.
Rob Packard (who helped extensively with this post) said,
And concluded, “I rely on these companies for referrals and information about the new EU Regs. These are the best of the best, and I can’t honestly recommend any of them right now.”
What is your experience with NBs? Are your timelines getting longer?
Who would you recommend?
How to Prepare a Medical Device 510(k) Submission for FDA
Speaking of Rob Packard, what a response to last week’s announcement for his 2.5-hour workshop. It’s still available at for $49 at http://medgroup.biz/submit-510k (Guests paid $325 to attend).
You get the presentation replay, slides, and handouts which explain the format of a 510(k), how to manage 510(k) projects, and what the requirements are for hardware and software product submissions.
That link again: http://medgroup.biz/submit-510k
Two California Events for Startups in January
JANUARY 10 MEDTECH SHOWCASE in SAN FRANCISCO
MEDTECH MONDAY in ORANGE COUNTY
I’ll be speaking at both of these events. Let me know if you’re coming so we can meet up.
Make it a great week.
Robert van Boxtel
Currently we have similar problems as described (no NB’s, no auditors….).
We discussed about this topic with companies with a similar company structure and realized, that there is a unspoken question:
What is the real objective of the new guidelines.
Often we also ask ourselves who created the new guidelines.
Christophe Tezenas du Montcel
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