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?
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?
How to apply the MDR
1) Assign an MDR representative for your company.
Give your team time to plan. More time sharpening an axe means less time chopping wood.
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.
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
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 design inherently safe
- Add protective safeguards
- Add written warnings or provide instructions
7) Submit 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.
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.
- 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
10) Seek Consulting & Training
This is my opinion.
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.
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