EMERGO SUMMARY OF KEY POINTS:

• The European Parliament’s approval of a final version of the Medical Device Regulations means companies now have a set regulatory text to help map out their compliance efforts.
• Emergo has identified and answered 10 key questions any company affected by the European MDR should be asking.
• Although the MDR’s date of application isn’t until 2020, manufacturers should be focusing on their transition plans to the new Regulation now.

Now that the European Parliament has voted to approve the Medical Device Regulations (MDR), many medical device companies active in Europe have begun mapping out how the new Regulations 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 EU Parliament-approved 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 May or June 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. This is not expected to happen before the end of 2018. “Old” Medical Device Directive (MDD) certificates may be used until they expire. One can continue to use the current MDD certificates, provided they have not expired, for four years after the date of application (May or June 2024).

2) Will unexpired CE Mark certificates be accepted during/after MDR implementation?

Yes. Unless suspended or withdrawn, all MDD certificates will remain valid until they expire, or until four years after the date of application (May or June 2024), whichever comes first.  Certificates issued under MDD Annex IV or Active Implantable Medical Device Directive (AIMDD) Annex 4, however, will remain valid until they expire or two years after the date of application (May or June 2022), whichever comes first. There are some conditions for using this "grace period;" no significant changes are allowed, the device needs to remain compliant with the current MDD, and new MDR vigilance and post-market surveillance requirements must be applied.

3) Will the MDR change how we oversee our critical suppliers?

The MDR includes provisions for unannounced audits, although so did the MDD. However, now, NBs must perform unannounced audits at least once every five years. 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/non reusable instruments?

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 registrar 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 own-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 and other evidence.

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 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.

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 (this has not changed from MEDDEV 2.7/1). The manufacturer must also be able to demonstrate equivalence by having access to equivalent device data, and the MDR even requires a contract between the manufacturer and the equivalent device manufacturer to access the technical documentation of that device. This will in practice mean that equivalence can only be claimed to devices for 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) This looks like a lot of work. Where do I start?

Indeed, this IS a lot of work and you should start as soon as possible. The first step is to make a transition plan for each of your devices and for your organization as a whole. Depending on the type of device, its technical maturity, the market, etc., a manufacturer could decide to aim for a strategy to be early, be late, or go for the middle.

Additional European MDR resources from Emergo:

• Whitepaper: Understanding the European MDR
• Whitepaper: MDR timelines and strategies
• Webinar: Overview of Europe’s MDR
• European CE Marking strategy support for medical device companies