Dec 15, 2020

On April 23, 2020, Regulation (EU) 2020/561 amending Regulation (EU) 2017/745 on Medical Devices (MDR) introduced a one-year delay in the date of application of the MDR. It also changed Article 59 of the Regulation:

  • Until the MDR applies, the current Medical Device Directives are also brought within the scope of Article 59.
  • While the MDR applies from May 26, 2021, Article 59 will apply from April 24, 2020.

Article 59 sets out how authorization of CE Marking requirements derogation for medical devices (not IVDs) can be done. In light of the COVID-19 pandemic, it may be justified to speed up the paperwork for devices that are being placed on the EU market, while at the same time Notified Bodies are struggling to perform audits and reviews while travel restrictions apply.

Article 59 guidance and CE Mark derogation

The European Commission has published guidance on this subject. This guidance specifies the following procedure for the derogation authorization:

  1. At least one Member State authorizes a derogation for CE Marking and notifies the European Commission about that;
  2. The justification for that derogation has been shared in full with the European Commission and the other Member States;
  3. The derogation has also been shared with the European Commission and Member States, as well as any result from surveillance and monitoring activities;
  4. The derogated devices must be clearly identified, because without the CE Mark it is likely the device is not registered in Eudamed or other relevant databases;
  5. All relevant documentation, including any technical documentation, that have been shared with the Member State must be shared with the European Commission and the other Member States.

The following criteria for derogation will apply:

  1. The manufacturer must demonstrate that it has tried what can reasonably be expected to get the device CE-Marked, as well as the reasons why this has so far not been successful;
  2. The device must be of vital importance;
  3. There are no substitutes (sufficiently) available;
  4. There are no indications of risks of the device for public health;
  5. Derogations are only temporary and the timeline should be in line with the expected timeline for achieving CE Marking;
  6. There is an EU-wide relevance for extending the validity of the national derogations.

Union-wide derogations will be adopted by means of an implementing act. Individual Member States may impose stricter conditions than those specified in the implementing act. The Union-wide derogation may only be given for a period of six months. The Medical Device Consultation Group (MDCG) will be consulted as part of this process.

Learn more about European MDR compliance and timelines

Article 59 in practice: responsibilities to Competent Authorities

As a rule of thumb, a manufacturer should only start this process if their conformity assessment has advanced to the stage where they are ready for Notified Body review. The Competent Authorities will review the technical documentation. Although this may not entail the same level of scrutiny as a review by a Notified Body, these reviews can be hard on details; different Competent Authorities focus on different details, as well. Manufacturers should also have sufficient evidence of a working quality management system. It would be best to have a Notified Body certificate; other evidence will probably be challenging to source and provide.

The next step involves determining the urgency of the derogation. The manufacturer must therefore produce evidence the device cannot be replaced without unacceptable risks and this evidence must be able to stand scrutiny by the authorities. The manufacturer must also consider alternatives and demonstrate why these alternatives will not be adequate.

If a device is made available in multiple Member States, multiple Competent Authorities will be involved. They will each have their specific additional questions and procedural requirements. Some Member States will grant authorization for three months, while other will go for six and there may also be Member States that refer to other timelines. They want to be kept updated on incidents, not only in their territory, but also in other Member States. Some, but not all, may also want to be kept updated on global vigilance reporting. Most of them will ask for periodic updates regarding the numbers of devices distributed and/or used in their territory, sometimes with additional reporting on complaints other than the reportable events they have already received.

A manufacturer relying on the Article 59 procedure will be faced with a lot of additional work to keep Competent Authorities informed and to keep their devices derogated. It is also clear that the ongoing COVID-19 pandemic, Brexit as well as the upcoming application of the MDR are draining resources at the Competent Authority level. There can be delays in responding, and there are indications of processes being under pressure. This is also not helped by the feeling that until recently a majority of Member States had not adapted Article 59 while still relying on the procedures from the Directives.

European Commission's role in derogation processes

Obviously the complexity of having to meet requirements from multiple individual Member States introduces extra work and an increased risk of errors. Those errors may even occur on the part of the Competent Authorities. These errors present the risk of derogation being cancelled, which may trigger other Member States doing the same. Having the European Commission taking over the derogation could therefore be a way to simplify this process and control such risks.

The European Commission is basically there for the Member States and should not interact directly with EU citizens. That means that any Union-wide derogation will be delegated to the Member States. At this moment no Union-wide derogation has been granted, so there is no in-depth experience with this. However, it can be expected that the European Commission will reach out to one Member State to coordinate this derogation. This will likely be the Member State where the manufacturer or its Authorized Representative is based, but this is not set in stone. That coordinating Member State may also communicate directly with the Notified Body involved in the certification of the device.

Conclusion: When is use of Article 59 appropriate?

Article 59 enables compliant devices that are not CE-marked to be made available on the European market if they are urgently needed. Manufacturers should, however, understand that this is not a free ride. The level of evidence that needs to be provided is similar to that required for CE Mark certification, and manufacturers must prepare for frequent and detailed post-market reporting. The level of detail and scrutiny, and the pressure on any ongoing certification process, will further increase if the derogation is leveraged to Union level. It appears that in practice the derogation should only be considered in conjunction with an ongoing CE Mark certification at a Notified Body.

Ronald Boumans is Senior Consultant, Regulatory Affairs at Emergo by UL.

Additional European MDR and CE Marking resources from Emergo by UL:

Author

  • Ronald Boumans

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