The European Medical Device Regulation 2017/745 (MDR) is the new set of regulations applying to all medical devices intended for market in the EU, replacing the previous Medical Device Directives (MDD) and Active Implantable Medical Devices Directive (AIMD).
Summary of Important Dates for Manufacturers
- May 2017, the MDR is published with an initial effective date of May 2020.
- May 2020, the effective date of MDR was postponed by 1 year due to the Covid pandemic.
- May 2021, the MDR becomes applicable and enforceable. All new devices or devices with expiring certification must now be MDR compliant.
- Dec 2027, all Class IIB and Class III device certificates issued under the previous directives that have not yet expired will no longer be valid.
- Dec 2028, all Class I and Class IIA device certificates issued under the previous directives that have not yet expired will no longer be valid. All medical devices marketed in the EU should now carry the MDR CE certificate.
What Do Manufacturers Need to Know?
The first step for all manufacturers will be to determine if their product is defined as a medical device or accessory under the new MDR. Once you have confirmed that the MDR is applicable to your device, it must be carefully classified based on invasiveness, contact duration, risk, and intended use. The MDR has four medical device classifications:
- Class I
- Class IIa
- Class IIb
- Class III
Classification defines the required level of involvement of a Notified Body in the certification process, as well as the depth of evaluation, vigilance, post-market surveillance, etc., required for a given medical device.
Transition deadlines for currently marketed devices are also based on this classification, so confirming that this determination has been made correctly is important.
The MDR requires significantly more documentation, including the below:
- General Safety and Performance Requirements (GSPR) – Annex I
- Quality Management System (QMS) – Article 10
- Technical Documentation – Annex II
- Clinical Evaluation Report (CER) – Annex XIV
- Post-Market Surveillance Plan – Annex III
- Economic Operator Agreements – Articles 11-14
- Person Responsible for Regulatory Compliance (PRRC) – Article 15
As noted above, specific requirements are determined by device classification.
Notified Body Coordination
Many Notified Bodies (NBs) designated under the previous directive (MDD) did not go through the process of MDR designation, so it is important to confirm whether your NB is designated under MDR. If not, you will need to change NB to continue working on MDR certification for your device.
To make the transition process as smooth as possible, it is strongly recommended to build a good working relationship with your NB so that you can understand their expectations for document review and best practices.
Achieving your CE Mark
Lastly, it is recommended to start the transition process as early as possible. Even though the MDR transition has now been delayed, wait times to receive CE markings are significant as Notified Body capacity is still a strong bottleneck in the process. Additionally, significant changes and additional documentation may be required for your device which will require adequate time to compile and review. Lastly, as defined in the amendment to MDR, extensions are intended for devices that have already shown progress in the transition to MDR.
Most manufacturers will need to take a mixed approach to certify 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.
Can Nelson Labs help my device reach compliance?
Understanding these new regulations and getting prepared to meet them is no small undertaking. Nelson Labs experts can help you guide you through this process to understand your testing needs, achieve certification, and get your products safely to patients who need them.
Let us help you create a gap analysis and a clear strategy for meeting this new MDR to avoid non-compliance and reduce unnecessary testing and documentation.
For additional assistance navigating regulatory requirements, contact our Regulatory and Advisory Services experts.