The European MDR: learn from my mistakes

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The European Union Medical Device Regulation protects patient safety and encourages medical device innovation. Companies that embrace the opportunity will succeed; companies that complain will not. Either way, society benefits.

This article is to help you learn the MDR using a product I co-invented and commercialized in 2004, demonstrating how to apply modern MDR regulations. I describe that product in another article. This article helps you learn from my mistakes.

My Mistakes

In 2004 I managed both engineering and marketing for a small medical device company. We developed products faster than competitors, rapidly grew sales, achieved twice the profit margin as competitive products, and were acquired by a large company for $42 Million.
Our board members profited, employees moved on to higher levels of responsibility in new companies, and I became president of a company formed around technologies I invented and co-invented.

Years later, I would learn that our first medical device eventually caused unnecessary pain and suffering for many patients and added unnecessary expenses to America’s healthcare costs. In this article, I re-analyze our product using modern design controls, risk management, and the European Union Medical Device Regulation; and I share lessons learned in leadership and entrepreneurship.

The background is explained in another article, Medical Devices: learn from my mistakes. I suggest reading that first to understand the product and the loopholes that allowed us to commercialize it without a plan to monitor risk.

The European Union Medical Device Regulations (EU-MDR)

The European Union Medical Device Regulation protects patients by requiring that products continuously improve to reduce risk to patients. If it had been available when I lead development in 2004, patients would not have suffered. Hopefully, this article helps you understand the importance of the MDR and how to apply it at your company.

This application to the MDR is an example, and like any example is not a substitute for in-depth learning. To learn more, search my blog for EUMDR tags, or stat with my article on the EU-MDR Big Picture.

EU-MDR Plans

The most critical MDR requirement is to have a plan for each product or family of products, depending on the risk classification of your medical device. Low risk, Class I and Class IIa products have fewer requirements, higher risk, Class IIB and Class III products have more requirements.
Your plan must be specific to your product and must be presented in a way that’s clear, easy to understand, and unambiguous. Your plan must include how and when it will be updated and improved. Your company must prove that it follows each plan, and that you continuously improve assumptions in your plan, such as risk probability and having reduced risk as far as possible.
You must have no doubt in the effectiveness of your plan, the ability for other people to follow your plan without further conversations, and the method that your plan will continuously improve for the life of each product.

Example MDR plan

This is a simplified plan – your plan would have to be more detailed, with clearly defined roles and responsibilities unique to your company’s quality system.

Scope
This MDR plan is for the Viper distal radius plating system, a medical device to treat distal radius fractures of the wrist. The product has been available commercially, but with limited documentation. This plan collects existing data and applies regulations from the European Medical Device Requirements for eventual sale in Europe.

References

  • Product history
  • Risk Management Plan
  • Produce Design Controls
  • Verification & Validation Trace Matrix document, VerVal-TraceMatrix.doc
  • Design and Manufacturing Master Validation Plan, DM-MasterVVplan.doc
  • Manufacturing processes, ManufacturingProcess.doc
  • Manufacturing process validation plan, ManufacturingProcessValidationPlan.doc
  • List your quality system policies, standards used or referenced, etc.

Indications for Use

The Viper is intended to treat distal radius fractures of the wrist or patients between 16 and 70 years old, between 120 lbs and 250 lbs, with strong bone quality and no evidence of osteoporosis or other bone-weakening diseases. The surgeon should be provided Viper instructions for use prior to surgery.

Product Description

The Viper distal radius system is a plate with two sizes of screws, 5.6mm diameter screws for the longbone and 2.5mm diameter screws for the distal end of the bone. The implant system comes with an instrument tray, screw drivers, screw drill guides, and a locking key to lock the 2.5mm screws to the plate.
For the sake of space and time, this example will focus on the plate, 2.5 mm screws, and screwdriver.

Classification

Plate: Class III
Screws: Class IIa
Screwdriver: Class IR

Registration

All products shall be registered in the EUDAMED system, and CE marking shall be obtained prior to selling in the European Union. (After registering, you’d enter your registration number here. This number may change if you significantly modify your product.)

Clinical Data

Clinical data shall be updated every year per the Viper Clinical Data Plan, and reported in the Viper Clinical Data Report. At a minimum, it shall include resources from five peer-reviewed medical journals, three competitive products, and one alternative treatment. Clinical data shall include both favorable and unfavorable comparisons whenever possible. Current clinical data is summarized below:
Literature Sources:
Competitive products:
Alternative treatments:

Clinical Evidence (summary of clinical data):

Risks from surgical implants include irritated or torn tendons, complications from surgery, and infection. Complications from surgery are and infection are common risks with all implants and are addressed in our instructions for use and demonstrated by negligible reports from post-market surveillance. Irritated or torn tendons is estimated to occur in 40% of competitor products that have protruding screws, which are estimated to occur in fewer than 5% of surgeries. The Viper post-market data is within these values.
Clinical data is usually a separate document. It includes data your organization believes is sufficient to support claims and make informed decisions and support claims. It should include scientific literature, competitive products, alternative treatments, and any data from your product’s post-market surveillance or clinical trials. Each company is responsible for determining the amount of clinical evidence necessary to support their claims.

Post-Market Surveillance

Post-market data shall be updated every year per the Viper Post-Market Plan, and reported in the Viper Post-Market Report. Post-market data shall include both favorable and unfavorable comparisons whenever possible.

Post-Market Surveillance Update Report

A PSUR shall be issued to the notified body responsible for overseeing our company’s compliance with European regulations. It shall be in the format provided by company procedures, PSUR-corporate-template.doc, and provided every time a post-market surveillance report is updated or after a reportable incident for product safety.

Risk-Benefit Statement

Risks shall be reduced as far as possible, and methods in the Risk Management Plan shall be followed.
The benefit of distal radius plating vs. the risks of surgery are justified according to clinical data and state of the art for wrist fractures; the general consensus of society is that benefits outweigh risks for distal rating surgery, shown by evidence in our clinical data.
The Viper distal radius system has features different than what’s commonly on the market. Additional risks from those features are:
  • If a screw were not inserted flush with the plate, tendons could be exposed to sharp edges and rupture.
  • If a surgeon stripped a screw trying to make it flush with the plate, it could become stuck and require additional surgery time to remove and replace the screw.


The added benefit to patients is additional flexibility in treating complex fractures, the ability to pull bones together during surgery, and the ability to avoid fracture lines when inserting screws. These benefits are used to market the Viper system, and residual, additional risks are clearly indicated in written instructions for use and our webpage.

Risk control was applied per ISO 14971, modifying the design of Viper’s screwdriver to minimize stripped screws and adding a drill guide to minimize off-centered holes that could lead to protruding screws. Risk controls are monitored for effectiveness in the Post-Market Surveillance plan, which includes Risk Analysis in the Viper Risk Management Plan.

With current data, the signing team of this document believes that risk has been reduced as far as possible compared to state of the art, and that residual risks of screws protruding are outweighed by additional benefits to the patient of treating complex fractures not possible with other technologies.

This statement shall be reviewed and updated every year.
The amount of risk-benefit analysis will depend on the risk category of your product, how common of technology you use, etc. Other companies following the MDR will be continuously improving products, therefore you must continuously improve your product and re-access the risk-benefit statement.

Technical Documentation

  • Design documents, plate
    • See Design Plan, ViperDesignPlan.doc
    • Design input.doc
    • Design drawing 1.doc
    • Design drawings 2.doc
    • Design drawings 3.doc
    • Design drawings etc.doc
    • Verification Test Protocols and Results .doc
  • Design documents, screws
    • See Design Plan, ViperDesignPlan.doc
    • Design input.doc
    • Design drawing 1.doc
    • Design drawings 2.doc
    • Design drawings 3.doc
    • Design drawings etc.doc
    • Verification Tests Protocols and Results .doc
  • Design documents, screwdriver
    • See Design Plan, ViperDesignPlan.doc
    • Design input.doc
    • Design drawing 1.doc
    • Design drawings 2.doc
    • Design drawings 3.doc
    • Design drawings etc.doc
    • Verification Test Protocols and Results .doc
  • Design documents, system
    • System drawings .doc
    • Instructions for Use .doc
    • Validation test protocol and results .doc
  • Manufacturing documents, plate
    • See Manufacturing Plan, ViperManufacturingPlan.doc
    • Plate Manufacturing process 1.doc
    • Plate Manufacturing process 2.doc
    • Plate Manufacturing process etc. com
    • Plate Manufacturing Process Validation .doc
  • Manufacturing documents, screws
    • See Manufacturing Plan, ViperManufacturingPlan.doc
    • Screw Manufacturing process 1.doc
    • Screw Manufacturing process 2.doc
    • Screw Manufacturing process etc. com
    • Screw Manufacturing Process Validation .doc
  • Manufacturing documents, screwdriver
    • See Manufacturing Plan, ViperManufacturingPlan.doc
    • Screwdriver Manufacturing process 1.doc
    • Screwdriver Manufacturing process 2.doc
    • Screwdriver Manufacturing process etc. com
    • Screwdriver Manufacturing Process Validation .doc
  • Manufacturing documents, system
    • System drawings .doc
    • label information .doc
    • Final inspection protocol .doc
  • Post-Market documents: Post-market plans and data for all components and accessories of the Viper plate are described in the following documents:
    • Viper Post-Market Plan .doc
    • Viper Post-Market Report .doc
  • Clinical documents: Clinical data for all components and accessories of the Viper plate are described in the following documents:
    • Viper Clinical-Data Plan .doc
    • Viper Clinical-Data Report .doc
  • Risk Management documents: Risk management plans and summaries for  all components and accessories of the Viper plate are described in the following documents:

What’s required in technical documentation is clearly identified and listed in Appendix ???? of the EU-MDR. Simply copy what “shall” be included before adding what you think “should” or “could” be included.
All that’s required is for that your layout be clear and easy to understand, a story that an auditor could follow without needing to ask questions. For the sake of space and time, this plan will be a simplified example of technical documentation – see the MDR for a complete list of what’s required.

Continuos Improvement

Though not required, I always recommend that companies add the exact method that each plan will use to continuously improve.

Lessons Learned

In the 15 years since launching this product, I’ve taught design controls to students in college and high school, R&D teams, and corporate executives. Many lessons are difficult to convey in words, such as how to make an effective plan.
  • Any acquiring company must either adhere to the plan or justify why they change it, and all changes must be maintained in their document system for future teams to access.
  • Long-term efficiency improves with effective plans. Quick meetings are short-sighted; the time saved moving forward that week costs many months of inefficiency and miscommunications later.
This sounds simple enough, but what one person considers to be a clear, easy to understand, and unambiguous plan may not be what another person considers to be a clear, easy to understand, and unambiguous plan.

The most important areas for continuous improvement is reducing risk to patients. Our product had additional risks compared to what was already on the market. I cover Risk Management in another article based on this product: Risk Management: learn from my mistakes.
Lessons learned aren’t limited to quality assurance, they includes leadership techniques and managing “up,” leading executives when you’re middle-management. The best way is usually the middle way, balancing an ideal scenario with the realities of each situation. I share those lessons throughout my blog, including tips for patenting new inventions and methods to accelerate development. But no amount of reading beats real-world experience, continuously improving based on real-world data, the same thing that an effective quality system does to a company.
Some lessons are only useful if society is aware of the problems with current medical device regulations.  That’s how the EU-MDR began, citizens demanded improved safety after 400,000 people received toxic implants.
Similarly, the United States media is starting to cover medical device failures, death and suffering, and excessive profits at the expense of patient safety.

We can all contact our senators and congressmen and request that they pass laws to revise the FDA to require continuous improvement from medical device and drug companies using the best aspects of the EU-MDR as a starting point.

Parting Thoughts

I consult healthcare corporations on international medical regulations and teach entrepreneurship at universities and in under-served schools. I allow companies to pay nonprofits in equitable healthcare and education instead of paying me. My goal is to help people who help others, and I hope my blog helps you identify unmet patient needs, innovate solutions, and advance healthcare for all of society. I wish you luck.
Please share this if you think others would find it useful.