Medical Device Regulation—EU MDR (2017/745)
On 25 May 2017, the European Union adopted a new set of regulations that replaces the Medical Device Directives (MDD) 93/42/EEC and Active Implantable Medical Devices Directive (AIMD) 90/385/EEC. It applies to all medical device manufacturers who intend to market their devices in the European Union. The new Medical Device Regulations (MDRs) become applicable and enforceable May 2020 allowing, for a 3-year transition period. After May 2020, all new devices and any devices with an expiring CE mark must comply with the new MDRs. This means that devices CE marked under the old MDD or AIMDD may no longer be marketed or put into service unless they have been resubmitted and fully comply with the new MDRs. By May 2025, the only medical devices allowed on the market in the European Union will be those conforming to the new MDRs.
A few of the key changes for medical device manufactures include:
- A wider scope of regulated medical devices—some devices will be “up classified”
- Greater premarket scrutiny for high-risk devices
- More stringent clinical evidence and documentation requirements
- A strengthening of post-market surveillance
- No devices will be grandfathered under the new MDRs
Some Important MDR dates for medical device manufacturers:
- May 2017, the MDRs are published and the 3-year transition begins
- May 2020, the MDRs become applicable and enforceable
- All new devices or those devices with expiring certification
- All Class I, self-certified devices and custom-made devices (excluding Class III implantable) must be compliant to the MDR
- Class I reusable surgical instruments, Class III implantable custom-made devices, devices new to MDR scope, and devices up-classified from Class I self-certified must be certified by a Notified Body
- Combination products of a pharmaceutical and a medical device that are considered medicinal products must comply with the General Safety and Performance Requirements, with notified body involvement if applicable
- Clinical investigations must comply with the MDR
- All post-market surveillance requirements of the MDR apply
- May 2022, certificates issued in accordance with Annex 4 of AIMDD and Annex IV of MDD that have not yet expired will become void
- May 2024, all other certificates issued under current directives that have not yet expired will become void
- May 2025, devices that were CE marked under the MDD or AIMDD may no longer be marketed or put into service in the European Union—only MDR CE certified devices are allowed.
How do these dates affect me?
Depending on the type of device you wish to market and the type and date of certification these currently have, will determine the urgency of getting your device certified under the new MDRs.
As many companies will be hurrying to certify under the new MDRs, you will want to get your device MDR certified as soon as possible if your:
- Device is currently Class 1 self-certified, but will be Notified Body certified under the MDR
- Product is not currently considered a medical device, but will be under the MDR
- Clinical evidence is sufficient for your device
- Device is CE marked now and you expect to make design changes in the next few years
- Device that you are introducing is new
You may have a little more time if you:
- Are planning to introduce new devices between 2020 and 2021
- Currently have sufficient clinical evidence
- Follow annex IV of the MDD or annex 4 of the AIMDD
- Will not be changing Notified Bodies
You may even have, or need, more time to get your device certified, if you:
- Have a CE mark now and do not expect to make design changes in the next few years
- Don’t expect the classification of your device will change
- Need more time to gather clinical data for existing CE marked devices
However, not all companies or products will fall neatly into one of these categories. Most will need to take a mixed approach to certifying their devices depending on the type and variety of devices they currently have, new products being introduced, the amount and quality of clinical evidence available, and the internal resources available to work on getting devices certified.
How can Nelson Labs Help You Comply with the new MDRs?
As you plan your MDR transition strategy, if you need help understanding the requirements, or want someone to help conduct a gap analysis of your current readiness for compliance, Nelson Labs has a team of expert advisors and a process available to help manufacturers bring their devices into compliance with the new MDRs. The details of the evaluation process will depend on the number and range of devices being evaluated and their clinical use history.
Understanding these new regulations and getting prepared to meet them is no small undertaking. That is why the expert advisors at Nelson Labs are ready to help you understand your testing needs and get your products certified and safely to those patients who need them.
Let us help you create a gap analysis and a clear strategy for meeting these new MDRs.