by Source Intelligence
on December 15, 2020
With around 27,000 medical technology companies representing a €110 billion industry, the European Union covers more than a quarter of the market, second only to the US. In total, there are over 500,000 medical technologies available worldwide.
Not only is the EU a hub for innovation, but it also has some of the most stringent laws regulating the medical technology sector. The new EU MDR is risk-based and designed to link a medical device to the risks it potentially poses to public health as a result of its components or possible malfunction.
While the directives classification system remains in application, several changes and additions have been introduced. As a result, MDR may be qualified as one of the most complex sets of requirements for medical devices to date.
Let’s go through everything you need to know to be ready for the 2021 start date and beyond.
The complexity of MDR necessitates that the transition span over several years, although high-risk devices (Class III) must meet compliance earlier. Considering the amount of preparation and work this new regulation represents, a couple of years is not long for preparation.
EU regulators may pride themselves on leaving no stone unturned. The text of the regulation clearly details the obligations of manufacturers and distributors to:
Since the purpose of the law is to ensure performance and safety throughout the entire lifecycle of the device, the EU places great emphasis on market vigilance which mostly falls under the manufacturer’s responsibility. In other words, companies placing medical devices on the European market are held responsible for their devices and must be able to demonstrate financial coverage in case a defective device is responsible for causing harm.
All companies producing medical devices destined to the EU must name a person solely responsible for regulatory compliance. Then and only then, they can draw up a declaration of conformity before applying for CE marking.
On a continuous basis, companies falling under the scope of EU MDR are tasked with entering and maintaining data in EUDAMED, including but far from limited to keeping the UDI (Unique Device Identifier) up to date.
Here are the tasks you need to include in your action plan:
These tasks are only the tip of the iceberg and each product may have it’s own unique sets of tasks needed as well.
Q. If your device received CE marking under the phased-out directives, can it stay on the market?
Q. Is meeting MDR compliance mandatory?
Q. Can you already apply for CE marking per MDR requirements?
Q. Is there really any rush to make the 2021 MDR deadline?
Q. Is the European Commission offering specific guidance to transition from MDD to MDR?
Medical device manufacturers or distributors are not necessarily big entities that can dedicate large teams to compliance. In fact, of the 27,000 MedTech companies in Europe, 95% are of small to medium size and most have less than 50 employees. Monopolizing even a few of them to work on MDR full time is not an option: it would be too expensive and detrimental to core business functions.
Source Intelligence has developed a solution to automate and simplify data collection and reporting. Through a user-friendly and ergonomic interface, you can:
Because EU MDR focuses so heavily on supplier documentation, the stronger your relationship with your suppliers, the better. With the myriad of compliance regulations out there, suppliers don’t always have the resources or know-how to provide the exact information you need.
With Source Intelligence’s EU MDR program, we take the heavy lifting off your shoulders and make it easy for suppliers to provide the data and documentation you need.
We make compliance easy, affordable, and timely. Request a demo of our EU MDR program to see what it can do for you.