With the final approval of the new EU Medical Device Regulation (MDR), companies have many questions on how to update their documents in order to maintain compliance. Below are some of the common question topics asked:
How long do I have to transition to the new MDR?
The MDR, replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), and has a transition period of three years. The regulation start date is May 25, 2017 so companies need to have their transitions complete by May 2020.
What devices are covered by the new MDR?
All devices covered by the previous Medical Devices Directive (MDD, 93/42/EEC) or the Active Implantable Medical Devices Directive (AIMD, 90/385/EEC) are included in the MDR. Annex XVI in the MDR provides additional information.
How will the new MDR impact contract manufacturers?
If a contract manufacturer intends to take on the legal manufacturer responsibility for the devices that they provide to market, they must comply with the regulation in its entirety.
Does the new MDR specify Unique Device Identification (UDI) requirements for the EU?
Devices must have assigned UDIs. A UDI must be included on in device labeling or else distribution the device cannot occur.
What are the changes to the requirements for clinical evaluation reports (CERs)?
Clinical evaluation is required and must be covered by plans and reports. Notified bodies will audit plans, procedures and results documented in CERs.
What are the changes to the requirements for post market clinical follow-up (PMCF)?
The PMCF is a “continuous process to update the clinical evaluation (Annex XIV, Part B).” This process will mainly drive the clinical performance evaluation, and must be based on real-life data. The results must be taken into account for clinical evaluation and risk management.
Will the new requirements be enforced retrospectively?
The new MDR requirements will be applied to all devices only when they are certified under MDR. After the transition period, devices not conforming to the MDR will need to be removed from the market.
Are there changes to device equivalency requirements in the new MDR?
The manufacturer must be able to demonstrate equivalence by having access to equivalent device data, and the MDR requires a contract between the manufacturer and the equivalent device manufacturer to review the technical documentation of that device. This will mean that equivalence can only be claimed to devices for which a manufacturer has access to technical documentation. Equivalent devices still need to be equivalent with respect to technical, biological and clinical properties to such extent that it can be demonstrated that there is no clinically relevant difference.