The MDR big picture

7 minute read.

The new European Medical Device Regulation will be required for all medical devices sold in the EU. This was motivated by European citizens demanding safer healthcare; the United States is considering similar changes.

This article is 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 that auditors can selectively apply portions 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 methods for reducing risk to patients, re-classifies some devices, and creates a way to track each device throughout it’s distribution system.

Devices must be re-designed to be as safe as competitive options. This will be proven for each device by submitting clinical data, which includes competitive products, and reports of your products compared to the competitive products.

Follow the steps below, where I broke the MDR into manageable topics.

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).

Give your team time to plan. More time sharpening an axe means less time chopping wood.

New classification rules for your devices are given in Annex 8.

Consider playing this game to learn the rules: I grouped celebrities who share the same medical devices and ask you to practice identifying the celebrities and classifying their medical devices. The game is structured like “Celebrity Jeopardy” from Saturday Night Live.

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

The MDR describes risk management methods in Annex 1, which is almost identical to ISO 14971.

ISO 14971 allows companies to accept some risks to patients based on business needs. The MDR requires that all risks to patients be reduced 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.”

This may be the biggest challenge for companies complying with the EU MDR. Reducing risk to patients As Far As Possible (AFAP) is a concept, not a definition. I try to demonstrate the concept through examples for people willing to follow links to deeper levels.

For the big picture, the MDR requires:

All risks must be reduced As Far As PossibleCost can not be a factor in risk controlBenefits to patients must outweigh remaining risks

Reducing risk as far as possible must be demonstrated for each product or family of products.

I can’t emphasize this enough: please read the article and understand the concepts rather than memorizing rules and applying them without seeing their impact on society.

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 “state of the art,” an ambiguous MDR concept in Annex 1.

Today, state of the art for car safety includes seatbelts, child safety seats, and recently rear-view cameras for backing up. Self-driving cars are available but we don’t have enough history for them to be considered “generally accepted state of the art.” Companies may choose to invest in self-driving cars as a business decision but must manufacture cars with state of the art safety features such as 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 share how to use the concept to reduce risk as far as possible.

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.

Accidental needle sticks by used needles are a public hazard. The design can’t be made inherently safe because needles must be sharp, so safeguards and written warnings are the only options and the remaining risks are outweighed by benefits to patients.

Reduce risk by applying risk controls. The priorities for risk control in ISO 14971 and the European Union are:

make the product inherently safeadd protective safeguardsadd written warnings or instructions

After applying risk controls to reduce risk as far as possible you must explain why remaining risks are outweighed by benefits.

7) Submit MDR reports

The EU-MDR will require paperwork that’s updated every 1-2 years depending on the classification of your device. Major changes from previous directives include:

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.

Technical Documentation (Annex 2): an extensive list of initial design requirements, production requirements, clinical data, post-market surveillance, etc. This replaces former “technical file” formats.

Clinical data and post-market surveillance must be updated for each device or family of devices to prove that you continuously improve based on state of the art healthcare. That’s fair.

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.

Yoda would approve of these Kaizen steps towards the EU MDR:

Appoint an MDR representative in your company.Reclassify your devices according to MDR rules.Schedule consultants to train or advise soon, they will become busy MDR approaches.

To learn more see my article “MDR: the medical device regulation formerly known as MDD.”

For example, Unique Device Identifiers will be required for all devices to ensure traceability throughout distribution, and Clinical Data and Post-market Surveillance reports will be necessary to document that you reduced risk As Far As Possible. These are described in details throughout 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. I wrote an article with tips-and-tricks for learning the MDR, which includes using original sources of information whenever possible and consider hiring consultants to help.

OFFICIAL REGULATIONS & PAPERS

CONSULTING & TRAINING

Maetrics

MDI ConsultantsGreenLightQunique, a botique company based in SwitzerlandMe (Jason 🙂

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. We have the opportunity to learn from the EU-MDR, but only if we tell our elected officials that it’s important and that our votes depend on their actions.

I believe that the EU-MDR is a starting point towards safer, more innovative healthcare. If a company or entrepreneur innovates safe designs that are beneficial to patients they become the new state of the art. Innovators win and society wins.

Consider the needle example. I said it couldn’t be designed inherently safe but that may change, but at one time people also said cars couldn’t drive themselves. This year several innovative car manufacturers released self-driving cars, which may one day be the generally accepted state of the art.

Companies that excel will be the ones that accept change, embrace ambiguity, and create a culture of continuous improvement.

THANKS

If you found this useful please share it so that others benefit.

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.

I work to help society have safer, more effective healthcare by helping companies increase efficiency and innovation. My interests include equitable education and innovative healthcare. Equitable means giving a bit more to those who start with less.

Peace.