“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,
• One of remaining four took 11 months to complete a Technical File Review for a client that paid for an expedited review that was promised to be complete in 45 days.
• Another let a client’s existing CE Certificate expire, because they did not have enough auditors to review the Technical File in a timely manner.
• A third refused to quote a new Certification Audit, because they were too busy and did not have enough resources.
• The fourth failed to provide quotes and turnaround projects in a timely manner for every client I know of.

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.”

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What is your experience with NBs? Are your timelines getting longer?

Who would you recommend?

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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

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Two California Events for Startups in January

JANUARY 10 MEDTECH SHOWCASE in SAN FRANCISCO
http://medgroup.biz/Medtech-Showcase-2017

MEDTECH MONDAY in ORANGE COUNTY
http://medgroup.biz/MedTechMonday

I’ll be speaking at both of these events. Let me know if you’re coming so we can meet up.

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Make it a great week.

Joe Hage
Medical Devices Group Leader

Stacy Livingston
Senior Consultant Obelis USA Branch, A leading provider of EU Compliance Solutions to companies worldwide for 30+ Years
You should also bear in mind that under the new criteria, Notified Bodies can no longer outsource to third parties with increased workload. All staff must be internal and this alone has hugely lengthened the turnaround.

Steven Maier
Regional Sales Manager – Healthcare at DNV GL – Business Assurance Accreditation / Certification / Training
wonderful information

Erik Vollebregt
Partner at Axon Lawyers
Robert Packard I expect litigation to be directed more to both governments and notified bodies. Both are wielding the stick more, without being able to back that up with sufficient capacity or expertise to solve issues. It will be a huge mess that will have its peak towards the end of the transitional periods for the MDR and IVDR, with many companies having to exit the market.

Rob Packard
510(k), CE Marking & Quality System Consultant
In response to Rebourgeard’s comments, LNE/GMED serves some of my clients very well. However, LNE/GMED is the smallest of the 4 NBs that are currently qualified for MDSAP. They do not have the resources to offer a high level of customer service to all clients and I have experienced times when they refused to quote. I do prefer this to no response or quoting and then failing to deliver. For some of my larger orthopedic clients with many Class 3 implants, LNE/GMED simply does not have enough qualified auditors.

Rob Packard
510(k), CE Marking & Quality System Consultant
A special thank you to Robert van Boxtel for providing a link to Erik’s new article. I have seen similar instances of problems with the Clinical Evaluations, but Erik brings up new issues of the Dutch authorities fining companies for nonconformities related to Class 1 devices and liability of NBs. I am shocked to see this come to pass. In the USA we have seen the FDA overstep their jurisdiction and lawyers have been needed to take the FDA to court. It seems the same will be needed in Europe.

Murali Kumar
Product Certification – CE, US FDA and QMS
Thanks for the post.

Michel Rebourgeard
Fondateur Tamu/ Conseil/Négociations/Ventes/Marketing/Stratégie/Développement/Gestion/Naming/Management projets/Gain
Once again if I can help anyone in finding a direct relationship with LNE/MED in france or GMED/NA in US just let me know about it and I will help!
In US https://lne-america.com/ and in France http://www.gmed.fr/pages/LNE-GMED-en-bref/adresses-contacts.asp

Annet Muetstege
Clinical Research Consultant at Applied Clinical Services BV
Thanks for sharing.

Ilan Goldberg
Sr. QA/RA Expert Medical Devices #EU MDR 2017/745 at Physio-logic Ltd.
Thank you Joe for sharing this important information from Rob Packard.

Julie Omohundro
Principal Consultant at Class Three, LLC
Catharina, raising the regulatory bar in any industry almost always results in some “cleansing,” as the companies that cannot meet the new requirements wash out.

Robert van Boxtel
Principal Consultant at MDProject
After spending a number of days in Israel, the hurting from Notified Bodies is felt there also.
Just returning, I found in my Inbox the blog from Erik Vollebregt. A definite must read for all interested in this subject.
https://medicaldeviceslegal.com/2016/12/15/the-authorities-are-not-your-friend-anymore-and-neither-are-notified-bodies/

Leonard Eisner
Medical Device Consultant, IEC 60601-1, Regulatory, Product Safety, Compliance, Quality Systems, & Internal Audits
I used to audit for TŪV SŪD & NSAI & with the MDR coming out around 2nd quarter 2017, the Canadian MDSAP requirements, & the new ISO13485:2016 they I’m sure are hitting critical mass. It’s also not easy to add personnel because requirements are getting harder to qualify the auditors. So, my clients aren’t happy about this either but needs to probably start planning for really long lead times & talking to their upper management to get more resources because delaying product to market times based on stories I’ve heard too. Sorry to ya I would plan to start getting in line as soon as you can. Good luck & cross your fingers maybe it will help!

Michel Rebourgeard
Fondateur Tamu/ Conseil/Négociations/Ventes/Marketing/Stratégie/Développement/Gestion/Naming/Management projets/Gain
I can also suggest the name of Corinne Delorme in LNE/G-MED in France who is totally devoted to customer satisfaction and I really have to say that I have no other motivation than to be honest in this testimonial and that I have no interest in any advice I could give for any NB. But I know much than very well this world and the French approach is really more than efficient and with a high level of services devoted to the patient and respecting all the rules. This GMED approach is truly a real added value but the central point is always the same: the patient must be the only concern that a society must have! And I never forget that all the time I worked in medical devices for 15 years.

Sean Spence
Regulatory Affairs Manager at NICO Corporation
Could not agree more, Joe. Has been quite a rough lately. We began the process of switching NBs in late 2015, only to find out the “larger” NB was also struggling with similar issues. In fact, even since the switch, 3 of the 4 examples Rob Packard said in your post have happened to us. Would be hard for me to recommend the ones I’m familiar with on the basis of customer service or turnaround times; would be solely on the probability of them still being around a few years from now. Definitely don’t envy their position, though.

Michel Rebourgeard
Fondateur Tamu/ Conseil/Négociations/Ventes/Marketing/Stratégie/Développement/Gestion/Naming/Management projets/Gain
Hello I worked for LNE in France and they are also in US. You can really call them in Paris or in US and they will and for sure call you back ! Tarik Krim is the CEO for LNE GMED NA and he is more than efficient and very attentive to customer satisfaction. So really think about LNE GMED the only one French NB and from my point of view they are on the top 3 in the world !

Catharina Biedermann
Servicemanager & Sicherheitsbeauftragte MP bei Medizin & Service GmbH, Servicemanager bei MedServ GmbH
Thank you Joe,
I have been working for a couple of years in a group of companies that deal with development, production, retail and service of medical devices.

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.
What is intended, a market cleansing or a increase of the of the safety of Medical Products?

Often we also ask ourselves who created the new guidelines.
Did they have practical experience?
Did they ever take part in an effective exchange of experience with a medium-sized enterprise?
Absolutely honest….I can’t imagine.

Alberto Paduanelli
Founder / CEO at ALPA Medical Ltd
Gavin Ritz, for Australia projects you should first approach TUV SUD in Singapore.

Christophe Tezenas du Montcel
Group CFO at IPSA SAS – Abiss/Aspide Medical/Baldrege/ID NEST Medical
NB are also late because they’re under much heavier scrutin now. They tend to ask for more information than before the PIP issue, therefore building up their own workload… at the expense of their customers, both timewise and moneywise. We’re on for a pretty long adjustment period.

Ivan Liljegren
Director QA&RA at Breas Medical AB
Notified bodies need to be innovative and make use of IT and offshoring to increase productivity. A lot could be done to streamline the routine tasks and let the scarce, qualified experts focus on truly value adding work .

Giuseppe Savoja
Business Director EMEA at Medtronic
Interesting.