How to learn the European Union Medical Device Regulation (EU-MDR)
3-minute read.
The new European Medical Device Regulation will be required for all medical devices sold in the EU. This was motivated by citizens demanding safer healthcare; the United States is considering similar changes. To learn more about the EU-MDR, do what Chuck Norris would do.
You could also read the official MDR and guidance documents online.
European Union Medical Device Regulation (EU MDR)European Commission Regulatory Summary & Guidance DocumentsEU Unique Device Identifier (UDI)2014 European Union consensus on applying ISO14971 to the EUMEDDEV 2.7.1 the guide for clinical evaluations
The MDR can seem intimidating. It’s 175 pages long, with 191,000 words and a few concepts that are unique to European law. To help you get started I consolidated online summaries, reputable consultants, and tips for searching the MDR for information you need.
SUMMARIES
BSI is one of the most established auditing companies in the world and recognized as a “notified body” by the European Union. They have free online summaries, a “road-show presentation,” and a 20-minute video highlighting the MDR.
TUV SUD is an international notified body. Their TUV America branch has a useful MDR summary and a flow-chart for the new MDR classification rules.
The EU-MDR Big Picture is a 7-minute article using pop-culture to emphasize key points, with links to learn more.
CONSULTING & TRAINING
These consultants and companies are familiar with the EU-MDR and could help your company with training, consulting, resources, and external audits.
Oriel STAT-A-MATRIXThey’ve operated internationally since 1968 with services ranging from training to consulting. (I consult with Oriel.)
GreenLight
They operate a useful blog
Qunique
Based in Switzerland, and their CEO, Angelina Hakim unites their community in collaborative workshops
TIPS & TRICKS
I prefer using an augmented version of the MDR from the consulting company Oriel STAT-A-MATRIX. They added a table of contents with hyper-links to pages, which I find it easier to use than the official version.
Answer these questions to practice using the MDR:
1) What are the core requirements to be on each Unique Device Identifier? Use Annex VI, Part B.
2) What are the minimum requirements of the post-market surveillance plan? Start with Chapter VII, Article 84, which is the technical documentation that will be required for your plan.
3) Learn the new classification rules, given in Annex 8. Consider playing a game where I grouped celebrities who shared common surgical treatments and ask you to classify their medical devices. The game is structured like “Celebrity Jeopardy” from television’s Saturday Night Live.
4) Search the MDR to learn if and when you should add product information to your company’s web site.
5) Search the MDR for the date that UDI will be required for Class III devices.
(It’s difficult to search for this question. As a hint, see “Final Provisions,” Chapter 10 (X), for many miscellaneous dates and conditional requirements, such as what to do if Europe’s medical device software system isn’t operational by 2020.)
To be effective using the MDR learn to search for keywords efficiently. To help, I wrote a guide for search techniques.
My opinion
My opinion stems from facts.
80,000 to 250,000 people die each yearfrom healthcare errors in the United States. 5 million people die world-wide from low-quality healthcare. Public awareness is increasing through news and documentaries like The Bleeding Edge. European citizens demanded government oversight after 400,000 people received toxic implants, which led to the MDR.
The United States is reviewing our regulations and I believe that the EU-MDR is an opportunity to learn. Its intention is to enforce methods of continuous improvement; the rules and penalties should encourage private companies to innovate safer medical devices. If a company or entrepreneur innovates safe designs that are beneficial to patients they become the new state of the art. Innovators are rewarded and society benefits.
Companies that excel will be the ones that accept change, embrace ambiguity, and create a culture of continuous improvement.
KEEP IN TOUCH
I post some articles on Linkedin or Twitter but most are in my blog. I email subscribers once a year or so.
My interests include equitable education and innovative healthcare. I work to help society have safer, more effective healthcare by helping companies increase efficiency and innovation. Learn more at JasonPartin.com
And, because life should be fun, here are my favorite Chuck Norris jokes:
