4 min reading time

If you do business in Europe, I heartily suggest you familiarize yourself – and quickly – with the changes in MDR 2017/745 and MDR 2017/746.

See http://bit.ly/EU-MDR-Labelling-Compliance

The EU Medical Device Regulation (MDR 2017/745 & MDR 2017/746) replaces the EU’s current Medical Device Directive (93/42/EEC) and EU’s Directive on active implantable medical devices (90/385/EEC).

It shifts regulation from the pre-approval phase (your path to CE Marking) to the entire product life-cycle.

This is what your peers said were their top concerns:
• Packaging said unclear requirements, time and resources, higher packaging costs, EUDAMED management.
• Regulatory said timelines and reclassifications, differences with UDI, post-market surveillance.
• Operations said the implant cards process, late implementation.
• Project Management said authorized representation, timelines and resources.

Full EU MDR implementation isn’t mandated until 2020, but I wouldn’t wait if I were you.

Labelling alone will be a headache, with a host of requirements that deviate from UDI regulations. Greatly abbreviating due to space (get the whole report at http://bit.ly/EU-MDR-Labelling-Compliance), note:
• Single-use devices: repackaging, sterilization, re-issued specs.
• New med dev symbol: will affect every single label.
• Clinical investigation: will affect every label and requires translations.
• Electronic labelling
• Electronic IFUs

In sum,
IF you do business in Europe
THEN you better know this stuff.

Thanks to my friends at PRISYM ID for the heads up.

That link again: http://bit.ly/EU-MDR-Labelling-Compliance

+++

Design Controls webinar tomorrow, May 23.

I’m hosting a webinar with Jon Speer from Greenlight Guru at https://medgroup.biz/design-control. It’s free for all Medical Devices Group members. Replay and slides available for all who register.

There’s already more than 1,000 registered. Grab your seat now.

+++

Make it a great week.

Joe Hage
Medical Devices Group Leader

++

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Iriny Ibrahem, no webinar, it is a PDF at http://bit.ly/EU-MDR-Labelling-Compliance

Julie Omohundro
Principal Consultant at Class Three, LLC
Here’s a link to a recent update from MedTech in Brussels last week:
http://qservegroup.com/i201/the-reality-of-the-eu-mdr-timelines
I noted that I’m not the only thinking the newly designated notified bodies may be turning away more clients than they have in the past, to the extent that some companies may find that no one wants to certify their devices.

Anne Leijsen
Head of Medical Writing at Factory CRO for Medical Devices and IVDs
The bad news: an immense increase in the requirements to conduct (post-market) clinical trials.

The good news? The requirements on how to perform your clinical trials don’t change much.

We wrote about the latter: https://www.factory-cro.com/news/clinical-investigations-changes-medical-device-regulation/

(And about PMS per MDR for class 1 devices: https://www.factory-cro.com/news/the-post-market-world-of-class-i-devices/ )

Emanuel Weisgras
Bringing worlds and cultures together through language.
Add to this the expected drop in notified bodies from ~50 to ~35, I sense an increase in sales for Norvasc and Ativan.

Italo Maddalozzo
Learning & Engagement – Helping companies change the way they communicate with employees through games
Thank you for sharing Joe Hage!

Christophe Dohen
Business developer – dispositifs médicaux (qualité, affaires réglementaires, conception, vérification/validation)
As already said, labelling is only one part of concerns. We can add clinical investigation especially for classe 1 MD, and for SME companies, the need to have an experienced employee for regulatory affairs tasks. The increase of cost for CE marking is a major concern. Audit from notified body will be more expensive, building the technical file will be more expensive.

Danny Lieberman
Physicist by training, medical device security expert, serial tech entrepreneur.
Anne Leijsen – sounds like an opportunity for good technology.

Raman Sinha
Zonal Sales Manager
ok thanks

Beluh Mabasa Ginting
Section Head of Standardization at Directorate of Supervision of Medical Devices and Household Health Ministry of Health
If the MDR is enforceable whether the regulatory authority’s definition is overridden or edited automatically..? (regulatory authority: A government agency or other entity that exercises legal right to control the use or sale of medical devices within it its jurisdiction, and may take enforcement action to ensure that medical devices marketed within its jurisdiction comply with legal requirements.

Michael Gasik
Professor at Aalto CHEM
Some my thoughts based on experience… may be useful for someone who is not very familiar with EU business:
1) MDRs are immediately enforceable in all EU simultaneously – no mediations into national law, override all national laws of the member states.
2) New rules also count these as MD: for the control or support of conception; cleaning, disinfection or sterilization of devices; contact lenses (even for a fun party!); dermal fillers; lipotransfer related devices; radiation-emitting devices , etc. (Annex XVI)
3) For manufacturers and R&D, please pay attention on implementation of Annex I § 10 and 11 into production and deployment chain. They are no easy to prove as might be seen at the 1st sight.
4) Unclear status of expert labs (Art. 106), who will be the judges?
5) For MD fans: fetch document 2012/0266(COD), it has comparison what was, what was planned and what comes.
Also there is ECJ case which resolution may force NBs to become responsible for “wrong” CE marking issuing….

Iriny Ibrahem
Senior Regulatory Affairs Associate
Unfortunately I missed this webinar, any chance to share slides presentation please

Robert van Boxtel
Principal Consultant at MDProject
To all readers of this post that now for the first time become aware of the MDR/IVDR in the EU, please realize. changed labeling requirements is just a small portion of the complete impact. Start analysing the impact for your organization and take action. Now. Or yesterday.

Ong Kean Seng
Senior Manager Regulatory Affairs at InOpharm
There are still so many grey areas that makes precise interpretation difficult during gap analysis. EC are slow in getting out their guidelines as well.