The MDR big picture

7 minute read. 

The new European Medical Device Regulation will be required for all medical devices sold in the EU by May 2020. These laws were motivated by European citizens demanding safer healthcare; the United States is considering similar changes. This article gives you the EU-MDR big picture, with links to learn more.

Why

Almost 400,000 people received toxic implants from one company under the former European medical device directives (MDD). A French company used industrial silicone instead of medical-grade silicone for breast implants, resulting in harm and suffering for patients and lawsuits against the manufacturer and lawmakers. 

When

• May 2017: the MDR "entered into effect," meaning auditors can selectively apply parts of it.
• May 2020: only MDR can be used for new products and "significant changes" to existing products.
• May 2024: only MDR certified products can be sold in the European Union.

How

The EU-MDR enforces reducing risk to patients and creates a way to track each device from the manufacturer to the patient. Tracking is done by scanned bar-codes between the manufacturer and the patient. Reducing risk is done by continuously improving products based on competitive options and real-world data.

Follow the steps below to comply with the MDR.

1) Assign an MDR representative for your company.

The MDR requires at least one person in your company be responsible for all regulatory compliance (Article 15). The MDR also requires that a management shall ensure a strategy for regulatory compliance (Article 10). 

You should give your MDR team time to plan. More time sharpening an axe means less time chopping wood.

2) Learn how to Classify Medical Devices

The extent of your paperwork and design verification is based on device classification. New classification rules are given in Annex 8 (VIII).

Learn the rules by playing this game, based on Saturday Night Live's "Celebrity Jeopardy", where I group celebrities who had similar surgeries and ask you to classify their medical devices.

3) Apply modern Risk Management

The space shuttle Challenger exploded in 1986. It became one of the most famous case-studies for risk management. I reanalyzed the space shuttle using modern methods from the international standard for risk management, ISO 14971,

MDR risk management methods are described in Annex 1 and are almost identical to ISO 14971.

ISO 14971 allows companies ignore some risks to patients based on business needs. The MDR requires that all risks be reduced As Far As Possible.

4) Reduce Risk As Far As Possible

In 1988 Chuck D, frontman of the hiphop group Public Enemy, asked "How low can you go?" In 2017 the European Union replied "As Far As Possible."

Reducing risk As Far As Possible may be your biggest challenge. It's a concept, not a definition. For the big picture, know that the MDR requires:

1. All risks must be reduced As Far As Possible
2. Cost can not be a factor in risk control
3. Benefits to patients must outweigh remaining risks

I can't emphasize this enough: please read the article to understand the concept rather than memorizing rules without realizing their impact on society.

5) Make State of the Art Devices

In the 1980's David Hasselhoff starred in television's Knight Rider, solving crimes with a self-driving and talking car.

I relate buying a car to reducing risk as far as possible, using a requirement in Annex 1 that medical devices must be "state of the art."

We can almost make David's 1980's super-car today, but that doesn't mean it would be state of the art. Today, state of the art for car safety includes seatbelts, child safety seats, and recently rear-view cameras for backing up. State of the art is not the latest technology, it's the "generally accepted state of the art." Companies may choose to invest in self-driving cars as a business decision, but they are required to add generally accepted state of the art safety features such as seatbelts and child safety-seat connections.

Government regulations can list require simple requirements like seatbelts or anti-lock brakes but are not efficient at complex concepts like medical device state of the art. I provide details in the article and give ways to make state of the art medical devices.

6) Give your risk-Benefit Analysis

This article uses Harry "The Hat" Anderson, magician and star of television's Night Court throughout the 80's, to illustrate the "point" of risk/benefit analysis using his needle-through-the-arm routine where he fumbles for written instructions only after having apparently impaled a giant needle through his arm.

This is analagous to the real-world risk of accidental needle sticks from used needles. A needle design must be sharp to do it's job, and written warnings are ineffective, so a company must apply safeguards such as caps for used needles. The remaining risks of sharp needles are outweighed by benefits to patients.

You must reduce risk as far as possible for your devices and explain how remaining risks are outweighed by benefits.

7) Submit MDR reports

The EU-MDR requires two reports: clinical data and post-market surveillance. Clinical data and post-market surveillance must be updated every 1-2 years to show that you continuously improve based on state of the art healthcare, and must be proven with technical documentation. That's fair.

Clinical data (Chapter 6 & Annex 14): proof that you investigated current medical treatments, competitive products, alternative treatments, your product's clinical history when relevant, and any other information that could be used to compare your medical device to "state of the art." You're expected to use the methods in MEDDEV 2.7.1.

Post Market Surveillance Update Reports (Chapter 7 & Annex 14): your product's real-world results, statistical trends, and other information that's necessary to maintain current clinical data and report adverse events to the European Union. PSUR's will help Europe monitor safety trends, alert citizens of risks, and develop common safety standards. Post Market Surveillance is so important that the MDR lists detailed steps on how to plan your work and incorporate it into product safety.

Technical Documentation (Annex 2): this has your clinical data and post-market surveillance and includes an extensive list of everything that proves you've reduced risk as far as possible, including initial design requirements, production requirements, test data, marketing literature, etc. This replaces former "technical file" formats.

To help, I reanalyzed risk analysis of a medical device I successfully designed and commercialized before the MDR. This time, I used the new MDR regulations and paperwork, and showed the risks that previous regulations allowed.

8) Take small steps

Taking small, manageable steps towards a larger goal is the Kaizen approach to management, based on the Japanese word for "improvement" and with roots in Buddhist philosophy, which was one of the influences for Yoda in the 1980 film Star Wars: the Empire Strikes Back.

To apply Kaizen you must understand what's unique to your situation and brainstorm which step would benefit your company the most; consultants can help.

9) Learn More

There's a lot more to know about the new MDR, formerly known as MDD. For example, each device must be traced throughout distribution, from the manufacturer to the patient using a Unique Device Identification label. The details are described in the 175-page European Medical Device Regulation.

Many details are out of scope for the Big Picture, which is why I recommend doing what Chuck Norris would do.

Chuck would politely ask me to help him.

But that may not be necessary. All requirements are available online, for free. My blog has tips and techniques to learn-by-doing, rather than reading summaries. But, use official documents whenever possible.

Read Official Documents

• European Union Medical Device Regulation (EU MDR)
• European Commission Regulatory Summary & Guidance Documents
• EU Unique Device Identifier (UDI)
• 2014 European Union consensus on applying ISO14971 to the EU
• MEDDEV 2.7.1 the guide for clinical evaluations

You could also politely ask the consultants below for help. Many offer corporate training, helping large groups of people become familiar with the MDR and other regulations so that you can work together more effectively.

Seek Consulting & Training 

• Qunique, a boutique consulting firm based in Switzerland (I know their CEO)
• Oriel STAT-A-MATRIX an international organization since offering quality and regulatory company since 1968 (I have consulted with them)
• LNE Group, a strategic consultancy, and their subsidiary notified body, GMED (I have known their employees)
• Me (Jason :-)

This is My Opinion

My opinion stems from facts.

80,000 to 250,000 people die each year from healthcare errors in the United States, 5 million people die world-wide from low-quality healthcare, and public awareness is increasing because of news and documentaries like The Bleeding Edge. European citizens demanded government oversight after 400,000 people received toxic implants, which led to the MDR.

I believe that the EU-MDR is a starting point towards safe, effective, and innovative global healthcare. Companies that excel will be the ones that accept change, embrace ambiguity, and create a culture of continuous improvement. To help society, our employees must be part of the process.

Innovators win and society wins.

Help

We need help. The U.S. Food and Drug Administration is asking for feedback from all people to ensure our laws are sensible and equitable. Proactive people will contribute today; reactive people will be frustrated tomorrow. Contact the FDA to see how you can help, or contact your congress person or senator to let them know your thoughts about safe and effective healthcare.

Summary

• The EU-MDR is a step closer towards safe, effective healthcare. It is required after May 2020; a few years later, any medical device not certified by MDR will be removed from sale in the European Union.
• The MDR is requried to sell medical devices in the European Union, which has 600 Million citizens and requires healthcare products from international manufacturers
• The MDR is public information, but it's long and complex. It can be simplified as: create linked processes of continuous improvement, centered around reducing risk to patients. This risk must be identified and monitored, and product design and manufacturing processes must improve to reduce risk.
• Consultants can help you and your teams apply the core MDR concept in ways that can be audited and inspected, so that you can sell products in Europe. Some consultants can do this while also helping you increase efficiency.

Thank you

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KEEP IN TOUCH

My interests include equitable healthcare and education.

Learn more at JasonPartin.com