Top 10 Questions about Europe's MDR for Medical Device Companies
EMERGO SUMMARY OF KEY POINTS:
- European MDR compliance involves a series of deadlines and implementation timeframes.
- In some cases, CE Mark certifications obtained under the existing European regulatory framework will be accepted for a limited time after the MDR comes into effect.
- The MDR will affect key manufacturer relationships with Authorized Representatives, Notified Bodies, critical suppliers and other counterparties.
Many medical device companies active in Europe are still in the early stages of mapping out how the new Medical Device Regulation (MDR) will impact their business. Based on feedback from clients as well as our own analysis of the MDR, Emergo has identified ten common industry questions and concerns regarding the new regulation.
1) What are the most important MDR implementation and compliance deadlines for manufacturers?
This is a complex question. For Class I medical devices there is a hard deadline at the date of application, expected in Q1 of 2020, but early compliance is allowed. Higher-risk devices may only switch to MDR certification once their Notified Bodies (NBs) have been designated for the MDR. “Old” Medical Device Directive (MDD) certificates may be used until they expire. Expiration times for certificates issued before the MDR date of application should not exceed four years; in theory, this implies that a manufacturer could potentially keep placing MDD-certified devices on the European market until Q1 2024.
2) Will unexpired CE Mark certificates still be accepted during/after MDR implementation?
Yes. Unless suspended or withdrawn, all MDD certificates will remain valid until they expire. Between the MDR date of entry into force (expected in Q1 2017) and the date of application (Q1 2020), NBs may issue MDD certificates with expiration times of four years. Certificates issued under MDD Annex IV or Active Implantable Medical Device Directive (AIMDD) Annex 4, however, will remain valid until they expire.
3) Will the MDR change how we oversee our critical suppliers?
The MDR includes provisions for unannounced audits. Critical suppliers should be integrated into manufacturers’ quality systems. This also means that any risks related to the production of a device must be identified and mitigated; an example of this is organizing a second, back-up source for a critical component of your device.
4) How will the MDR affect European market authorization for Class I non-sterile/non-measuring devices?
Whereas manufacturers of such devices must currently notify relevant Competent Authorities, they will be required under the MDR to enter data about their devices into the Eudamed database themselves. Such manufacturers will also have to set up quality management systems, although NB certification of these quality systems will not be required. Clinical data requirements will also increase under the MDR.
5) What will the MDR mean for off-brand labeling (OBL) of some devices?
Every manufacturer must have access to full technical documentation according to the MDR. This would require that OBL manufacturers hand over those files, which may not be easily done. It is expected that in practice this requirement will put an end to OBL manufacturing as we know it under the MDD.
6) Will there be more stringent NB requirements for clinical evaluation reports (CERs) under the MDR?
Yes, MEDDEV 2.7/1 Rev. 4 is a big step in the direction of the MDR requirements in this area. However, MDR goes further: Clinical evaluation is a permanent process that must be covered by plans and reports. NBs will assess plans, procedures and results documented in CERs.
7) How will the MDR change Post Market Clinical Follow-up (PMCF) requirements?
The PMCF is a “continuous process to update the clinical evaluation (Annex XIII, Part B).” This process will mainly drive the clinical performance evaluation, and must be based on real-life data. Its results must be taken into account for clinical evaluation and risk management.
8) Does the MDR introduce or specify any Unique Device Identification (UDI) rules for the European market?
Each device will have to be assigned a UDI. A manufacturer must obtain a UDI code from a UDI supplier, upload device-specific data into Eudamed and then link the UDI to that data set. After that, the UDI must be placed on the device label before distribution can occur.
9) Are there any changes MDR brings in terms of device equivalency requirements?
Equivalent devices 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. The manufacturer must also be able to demonstrate equivalence by having access to equivalent device data. This will in practice mean that equivalence can only be claimed to devices to which a manufacturer has access to technical documentation. So, this will in practice limit the use of equivalence to devices in the same families, or to equal devices in other generations.
10) Will the MDR’s new liability provisions affect the availability and/or number of Authorized Representatives (ARs) in Europe?
The MDR will make the Authorized Representative jointly and severally liable with the manufacturer. This will create a risk for the AR that will be difficult if not impossible to fully control. ARs will have to find a solution to this, although they will have some time yet to do that. This requirement will only affect devices placed on the European market on or after the MDR date of application, expected in Q1 2020. It can be expected that your AR will keep you informed; contact your AR if you have further questions.
Additional MDR information