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.
EU MDR Timelines
General Key Dates
- 26th May 2021: Date of application of the EU MDR (it becomes legally binding). The original 2020 deadline for application has been delayed due to the coronavirus pandemic.
- 26th May 2022: Earliest date EUDAMED is estimated to go live. The European Commission will make some EUDAMED modules available in 2021 but adopted the decision to delay its full application.
- 26th May 2024: certificates issued under MDD become void. This is the last date for placing medical devices on the market unless they meet MDR requirements.
- 26th May 2025: the last date for end-users (hospitals, for instance) to put MDD products into service
Implementation for Label and Packaging
- 26th May 2021: deadline for medical devices Class III and implantable
- 26th May 2023: deadline for Class IIa and IIb devices
- 26th May 2025: deadline for Class I
Implementation for Direct Marking and Reusable Devices
- 26th May 2023: for Class III and implantable
- 26th May 2025: for Class IIa and IIb
- 26th May 2027: for Class I
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.
MDR Compliance Scope of Duties
EU regulators may pride themselves on leaving no stone unturned. The text of the regulation clearly details the obligations of manufacturers and distributors to:
- have risk management and quality management systems in place,
- conduct a clinical evaluation,
- compile technical documentation,
- and apply conformity assessment procedures.
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.
MDR Compliance Checklist
Here are the tasks you need to include in your action plan:
Design Concerns
Product Concerns
These tasks are only the tip of the iceberg and each product may have it’s own unique sets of tasks needed as well.
Frequent Questions Regarding MDR
Q. If your device received CE marking under the phased-out directives, can it stay on the market?
- Yes. Consider the next few years as a transition period. The EU has no intention to renege on previously certified devices when those were in conformity with the directives. Pay attention to the expiration date and check against the timeline specific to your product class (remember it may fall in a different class now).
Q. Is meeting MDR compliance mandatory?
- If you are manufacturing for or distributing medical devices in the European Union, the answer is you must start transitioning toward complying with the new regulation. That being said, this new law is far from being an overnight switch. Implementation details are likely to emerge in secondary legislation over the next years, notably the functions and use of EUDAMED. The database is an ambitious program that is bound to evolve. Until then, the regulation provisioned for EU MDR expert panels that may assist in prioritizing, answer pressing questions concerning high-risk medical devices, and give directions.
Q. Can you already apply for CE marking per MDR requirements?
- Yes, and you should take a proactive approach regardless of the time the transition allows. However, the database, registration, and reporting requirements may take longer to be fully operational, which is why the EU has established such a calendar. You may want to first focus your efforts on data collection, products that are getting close to certification expiry, new products you expect to reach the market within a few years, so you avoid having to go back and fix the missing links.
Q. Is there really any rush to make the 2021 MDR deadline?
- Yes. Although deadlines vary depending on the risk level – or class – of your device, and despite some items still not fully released, Notified Bodies will get swamped as organizations rush to meet due dates. The earlier you enter the game, the fewer roadblocks you encounter and the more breathing room you get to iron out details.
Q. Is the European Commission offering specific guidance to transition from MDD to MDR?
- Yes. The Commission has published a factsheet for manufacturers, which is a step-by-step implementation guide and a rather exhaustive list of requirements and actions companies should take.
MDR Compliance Simplified with AI Technology
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:
- Upload the list of your suppliers
- Identify products that contain targeted substances per ECHA’s latest listing
- Drill down to the smallest level of a device that falls in scope of the regulation
- Centralize documentation and reports storage to quickly pull what you need
- Proprietary AI technology aggregates and validates data
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.
