The MDR Big Picture

The MDR big picture

7 minute read.

Any company that wants to sell medical devices in the European Union must follow new EU Medical Device Regulations. These new regulations were motivated by EU citizens demanding safer healthcare. This article is the EU-MDR big picture with links to learn more.

WHY the MDR?

400,000 people received toxic implants under the former European healthcare guidelines. A French company used silicone for breast implants that was rated for industrial services, not medical implants, resulting in implants that leach toxic chemicals and are prone to bursting.

WHEN is the MDR?

  • 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 does the MDR help?

The MDR requires that each device must be as safe as competitive options. If not, that device must be improved or taken off the market. Safety will be evaluated by comparing each device to clinical data, including competitive products and alternative treatments, and reports from real-world use.

How to apply the MDR

Follow the steps below, where I broke the MDR into manageable topics. To make it fun, I related each topic to pop culture.
The MDR Big Picture

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 MDR describes risk management methods in Annex 1, which is almost identical to the international standard for risk management, ISO 14971.

ISO 14971 allows companies to accept some risks to patients based on business needs. The MDR requires that all risks be reduced As Far As Possible, but uses the same systematic approach to risk management.

I reanalyzed the 1986 space shuttle explosion using modern methods, demonstrating how ISO 14971 saves lives and is easy to implement.

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.”

The MDR requires that for each product or family of products:

    • All risks must be reduced As Far As Possible
    • Cost can not be a factor in risk control
    • Benefits to patients must outweigh remaining risks
Reducing risk to patients As Far As Possible (AFAP) is a concept, not a definition or list of rules. I demonstrate the concept through examples, and provide links for people seeking deeper understanding.

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:

  1. Make the design inherently safe
  2. Add protective safeguards
  3. Add written warnings or provide instructions
After applying risk controls to reduce risk as far as possible you must explain why remaining risks are outweighed by benefits.

7) Submit reports

The EU-MDR will require paperwork that’s updated every 1-2 years depending on the classification of your device. This is in addition to initial paperwork, called Technical Documentation. Your company must demonstrate continuous improvement by continuously updating clinical data, post-market surveillance, and post-market surveillance update reports.

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

For Clinical Data (Chapter 6 & Annex 14), you must compare your product against competitive products, current healthcare science, alternative treatments, and any other information necessary to be considered state of the art. Many companies also use clinical methods in MEDDEV 2.7.1.

For Post Market Surveillance (Chapter 7 & Annex 14), you must track your product’s real-world results, statistical trends, and other information that’s necessary to maintain state of the art. In other words, your product becomes part of clinical data, and clinical data influences your product to become state of the art.

Post Market Surveillance Update Reports, PSUR’s, are brief summaries of your Post Market Surveillance will help Europe monitor safety trends, alert citizens of risks, and develop common safety standards.

Clinical data and post-market surveillance must be updated for each device or family of devices, demonstrating that your products continuously improve compared to state of the art healthcare.

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.

Understand what’s unique to your situation and brainstorm your next Kaizen step. As an example, I assumed a typical situation and wrote an article giving Kaizen steps towards As Far As Possible.

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. But, most consultants simply explain what is publicly available, so start by reviewing these regulations and guidance documents:

10) Seek Consulting & Training

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.

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.

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


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