The time-buying MDR trick you need to hear immediately

🔥 Find me at MedicalDevicesGroup.net 🔥

July 2019

4 min reading time

I stumbled upon a significant idea with regulatory and quality expert Michelle Lott last week. Seize it immediately! Here’s that 9-minute conversation.

Get or renew your CE mark TODAY!

If you prefer reading, the conversation highlights are:

Get or renew your CE mark today! Here’s why:
1. No CE mark, no sales. Medical device manufacturers active in Europe need a CE mark to comply with EU regulations.
2. The rules change May 26, 2020. The old regulation (the Medical Device Directive or MDD) is less restrictive than the European Medical Device Regulation (EU MDR).
3. CE mark certification lasts five* years. Theoretically, someone whose clock started on May 25, 2015 would be unable to sell product on May 20, 2020.
  I put an asterisk after “five” in this case because Article 120 of regulation 2017/745 states: […] Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall however become void at the latest on 27 May 2024.
  Therefore, a theoretical CE mark issued on 25 May 2020 under MDD would be valid for four – instead of five – years.
4. Conclusion: Reset the clock immediately! It will take – let’s say – six months to get or renew certification. Your ‘clock’ would start on December 2, 2019 (and expire on 26 May 2024, the latest possible date).
5. Don’t be cute. Don’t wait November 20, 2019 to attempt to “start the clock” exactly the day before. Five years from the ‘day before’ already passed! It was 23 May 2019. Apply today, today, today!
June 2025* is the last possible MDD-certified sale date. To illustrate, here is a chart (from MedTech Europe, click for the PDF) and three scenarios.
1. Your MDD certificate is dated February 2019. You can MAKE the device through February 2024. You can SELL it through February 2025.
2. Your MDD certificate is dated 26 May 2019. You can MAKE the device through 26 May 2024. You can SELL it through 26 May 2025.
3. Your MDD certificate is dated 26 May 2020. You can MAKE the device through 26 May 2024. You can SELL it through 26 May 2025.

No ‘significant changes’ to your MDD-certified product after May 2020. While you can SELL product as above, you can only MAKE the product that was certified under MDD. What constitutes a ‘significant change?’
That’s tricky, because each notified body has some license to interpret the clause.
So ask YOUR notified body. Or ask Michelle Lott.
(I help with Michelle’s marketing. We made this nifty explainer video for you.)
Will MDR be delayed? That’s my completely speculative bet. There’s too much to be done and only BSI and TUV SUD have been designated and notified under EU MDR.
Will your notified body get a designation at all? Who knows? But three agencies have already stated they’ll never get that designation.
What will their clients do?
“Need a Notified Body? Good Luck!” I wrote that article 2½ years ago! The situation is far more acute now.
I asked Michelle, “Given a shrinking number of notified bodies and their workload, do you have any advice on how to get someone to pick up the phone?”
“No,” came the sad reply. “you have to just call and call and call and call and call until you find somebody that is willing and able and has resources to do it.”

I’ll say it again.

If you actively sell medical devices in Europe,
STOP WHAT YOU’RE DOING
and Get or Renew Your CE Mark Today!!

There.

That ought to cover the price you paid for this free Medical Devices Group membership. 😉

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Make it a great week.

Joe Hage signature

Joe Hage
Founding Principal,
Medical Devices Advisory Group

P.S. Special thanks to Bassil Akra (TUV SUD), Oliver Bisazza (MedTech Europe), and Sabine Stridde (IMAGE Information Systems Europe GmbH) for their contributions and edits to this article.

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Posted by Joe Hage

Asked on July 2, 2019 3:09 pm

5254 views

	Private answer Joe Hage July 3, 2019. Edits have been made to this article. Special thanks to Bassil Akra (TUV SUD), Oliver Bisazza (MedTech Europe), and Sabine Stridde (IMAGE Information Systems Europe GmbH) for their contributions and clarifications. Marked as spam Report spam
	Private answer Joe Hage Julie Omohundro Principal Consultant at Class Three, LLC I will add that there are the deadlines in the MDR/IVDR, and there are the NB's deadlines. Many NBs have already given their clients deadlines for MDD renewal that are earlier than the dates in the regulations. Marked as spam Report spam
	Private answer Joe Hage Francisco Amez Navarro K.A.M. Hospitalario y Market Access. Labs. E.R.N. S.A. Good reflexion. Marked as spam Report spam
	Private answer Joe Hage Marc Hoewer Global Business Manager Distributed Products / OEM a bet with high stakes for doubtful improvements of patient safety in any Marked as spam Report spam
	Private answer Joe Hage Julie Omohundro Principal Consultant at Class Three, LLC Who's betting and what are they betting on? Marked as spam Report spam
	Private answer Joe Hage Marc Hoewer Global Business Manager Distributed Products / OEM Julie O.Joes speculative bet that MDR will (have to) be delayed ...or where Ratio meets EU politics Marked as spam Report spam
	Private answer Joe Hage Julie Omohundro Principal Consultant at Class Three, LLC Thanks, I missed that. As I understand it, the question is not if it will be delayed, but can it. I've been told that it can't, and I've been looking forward to finding out the truth of this for several years now. (edited) Marked as spam Report spam
	Private answer Joe Hage Mina Harris Sales Supervisor and Product Specialist at Misreya Medical, Egypt Great Marked as spam Report spam
	Private answer Joe Hage Matthias Bürger Vice President RA/QA EMEA at Zimmer Biomet As pointed out - you still need to change the article. You cannot MAKE products until May 2025. That stops in 2024. That last year is only for moving products already in the distribution chain. So while a product can be solving that last year it cannot be introduced to the market. Secondly - to be honest if you have not started and negotiated the renewals of your MDD CE certs by now, it is more than likely too late. All NBs are absolutely swamped. Marked as spam Report spam
	Private answer Joe Hage Julie Omohundro Principal Consultant at Class Three, LLC On the one hand, that is my impression; on the other, based on past experience there doesn't seem to be anything to prevent NBs from signing you up for renewal even if they don't have the bandwidth. And I've wondered if there is anything that prevents NBs from short-circuiting their usual renewal process and just issuing a bunch of certificates en masse at the deadline. Marked as spam Report spam
	Private answer Joe Hage Matthias Bürger Vice President RA/QA EMEA at Zimmer Biomet Julie O. We will see all Kinds of things happen when the real panic starts (April 2020 ?). Marked as spam Report spam
	Private answer Joe Hage Julie Omohundro Principal Consultant at Class Three, LLC Yes, seems likely. Best Regulatory Show Ever. Marked as spam Report spam
	Private answer Joe Hage Eckhard Jokisch Freelance ISO-13485:2016 Lead Auditor, QA/RA Outsourcing Expert,QA/RA Enthusiast There might also be some fun within Article 120 (3) when interpreting the word "and" in the term "provided there are no significant changes in the design and intended purpose." If treated as a logical AND then this is only true if you change design AND purpose. So if you only change the design you may continue to sell if you don't change the intended purpose or vice-versa. If the intention of Article 120 (3) is different then "and" would need to be replaced by "or". Marked as spam Report spam
	Private answer Joe Hage Eckhard Jokisch Freelance ISO-13485:2016 Lead Auditor, QA/RA Outsourcing Expert,QA/RA Enthusiast Another tricky point is Article 120 (3) if you change the intended purpose. Taken literally it does not only apply to extending of the intended purpose but also to reducing the scope of intended purpose. Marked as spam Report spam
	Private answer Joe Hage Eckhard Jokisch Freelance ISO-13485:2016 Lead Auditor, QA/RA Outsourcing Expert,QA/RA Enthusiast I think it is important to also look at the risks! You don't by time -you just postpone the pain. In case your device has a shiny new MDD certificate and you postpone MDR certification for later you might run into a situation where the device design needs a change due to problems in the field. Then your CE mark is void and you device is out of market in the EU. NBs are not able to recertify under MDD after 26th May 2020. Marked as spam Report spam
	Private answer Joe Hage Michael Gasik Professor at Aalto CHEM Yes, grandfathering is not allowed and loophole for personalized customized MDs tightens... Marked as spam Report spam
	Private answer Joe Hage Helen Pan ►Dental Equipment Supplier ★ Helping Dentists Save at least $10K when setting up a new practice.★ Great Marked as spam Report spam
	Private answer Joe Hage Joe Hage Chairman at MedicalDevicesGroup This updated chart courtesy of Oliver Bisazza and the hashtag#MedTechEurope team and, while I can't edit the image above, I did so for the article at medgroup.biz/mdr-trick , along with a link to the entire PDF. The MedTech Europe folks know this topic much, much better than I. (edited) Marked as spam Report spam
	Private answer Joe Hage Martin Holub “All is possible, nothing’s granted.” Highly relevant Marked as spam Report spam
	Private answer Joe Hage ADNAN ASHFAQ QA/RA MDR & Validation Consultant at Pharmi Med Ltd This is old news?! although clearly written, surely thats what NBs are busy doing - extending certifications! Marked as spam Report spam
	Private answer Joe Hage ADNAN ASHFAQ QA/RA MDR & Validation Consultant at Pharmi Med Ltd Michael Gasik you may want to look at our guidance docs on pharmimedtemplates.com Marked as spam Report spam
	Private answer Joe Hage Michael Gasik Professor at Aalto CHEM well, there are indeed many unclear points yet. Commission opened special section at portal, but not so much detailed info there. Also there are documents for borderline cases... Marked as spam Report spam
	Private answer Joe Hage Ingmar R. Kupferer, MBA (Open)Betriebswirt VWA Sales Director GUIDOR BDU No doubt - highly relevant and a key issue to address right away! Thank you for this content! Marked as spam Report spam
	Private answer Joe Hage Bassil Akra Vice President - Global Focus Teams This graphical overview refers to wrong dates and must be revised avoiding more confusion in a period of total uncertainty! Marked as spam Report spam
	Private answer Joe Hage Michael Gasik Professor at Aalto CHEM Yes, I also noticed - in the main feed more correct dates. Marked as spam Report spam
	Private answer Joe Hage Oliver Bisazza Serving the medical technology industry in Europe Indeed. See this for more accurate information: medtecheurope.org Marked as spam Report spam
	Private answer Joe Hage Julie Omohundro Principal Consultant at Class Three, LLC From a business perspective, there is no "Europe." There is the EU, EFTA, CEFTA, and CISFTA. And there is Brexit, which as of today is scheduled for October of this year. I'm not sure what that might mean for a 10x in London in February 2020, but it seems like it is something worth keeping in mind. Marked as spam Report spam
	Private answer Joe Hage Hermann Plank High Tech Consultant - Plastics Expert Witness as always - awesome content!!! Marked as spam Report spam
	Private answer Joe Hage Michael Gasik Professor at Aalto CHEM Situation with MDR and NB even more dramatical. There are an ECJ case - if passes, NB will have financial liability if their compliance certificate will fail (in reality more complex). Expecting MB fees to rocket... 🤨 Marked as spam Report spam
	Private answer Joe Hage James Bell, MBA Medical Devices & Digital Health Consultant \| Strategy, Commercialization & Leadership \| Serving Startups & Investors Brilliant! Marked as spam Report spam
	Private answer Joe Hage Michael Gasik Professor at Aalto CHEM Not exactly - main revolution is change from Directive to Regulations, this is new policy + of course a set of tightening stuff. You may fetch working doc 2012/0266(COD), it has comparison between old and new rules. Marked as spam Report spam
	Private answer Joe Hage ADNAN ASHFAQ QA/RA MDR & Validation Consultant at Pharmi Med Ltd No the fact that companies should benefit from the grace period article 120 has been in motion since the release of the EU MDR in 2017 many companies already submitted their certificates for extension with their notified bodies, this is not new information besides the infographic missing all the new information, which is why this is slightly outdated Marked as spam Report spam

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