EU MDR Article 59 and CE Marking for Medical Devices
Derogation from the conformity Assessment Procedure
In 2020, Regulation (EU) 2020/561 which amends Regulation (EU MDR) 2017/745 previously introduced a one-year delay in the date of application of the MDR. Article 59 was also changed:
- The current Medical Device Directives were also brought within the scope of Article 59 until the MDR applies.
- While the MDR is applicable from 26 May 2021, Article 59 applied from 24 April 2020.
Article 59 sets out how authorization of CE Marking requirements derogation for medical devices (not IVDs) can be done. We would recommend accelerating the paperwork for devices being placed on the EU market.
Article 59 guidance and CE mark derogation
The Commission will first consult the Member States through the Medical Device Coordination Group (MDCG) established under Regulation (EU) 2017/745 to determine if a notified national derogation for a medical device is relevant to the Union.
After determining Union-relevance, the Commission will consider if sub-section A procedural requirements have been met. In the third phase, the Commission will decide whether a Union-wide derogation is justified based on the requirements in sub-section B.
The published guidance specifies the following procedure for the derogation authorisation:
- At least one Member State authorises a derogation for CE Marking and notifies the European Commission;
- The justification for that derogation is shared in full with the European Commission and the other Member States;
- The derogation is also shared with the European Commission and Member States, as well as any result from surveillance and monitoring activities;
- The derogated devices must be clearly identified. Without the CE Mark it’s likely the device is not registered in Eudamed or other relevant databases;
- All relevant documentation, including any technical documentation, that has 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:
- The manufacturer must demonstrate that they have tried what can reasonably be expected to get the device CE-Marked. They must also give the reasons why this has so far not been successful;
- The device must be of vital importance;
- There must be no sufficient substitutes available;
- There must be no indications of risks of the device for public health;
- Derogations are only temporary. The timeline match the expected timeline for achieving CE Marking;
- There is an EU-wide relevance for extending the validity of the national derogations.
Implementing acts will establish EU-wide derogations. Member States can apply stricter criteria than the implementing act. Union-wide derogation can last six months. This process will involve the MDCG.
Article 59 in practice: responsibilities to Competent Authorities
A manufacturer should only start this process if their conformity assessment is ready for Notified Body review. The Competent Authorities will review the technical documentation. These reviews may not be as detailed as a Notified Body review, but Competent Authorities focus on different details. Manufacturers should also demonstrate a working quality management system. A Notified Body certificate is best as other evidence may be difficult to source and provide.
The next step is determining the derogation urgency. Thus, the manufacturer must prove the item cannot be replaced without unacceptable risks and the evidence provided must pass authority scrutinization. The manufacturer must also investigate alternatives and show why they are inadequate.
A device sold in multiple Member States will involve multiple Competent Authorities. Each has unique questions and procedures. Some Member States authorise for three months, others for six, and some for additional durations. They want updates on incidents in their country and other Member States. Some may additionally want worldwide vigilance updates. Most of them will want periodic updates on device distribution and use in their jurisdiction, often including complaints beyond the reportable events they have received.
The European Commission’s role in the derogation process
Meeting the regulations from multiple Member States adds work and increases error risk. Competent Authorities may also make those errors. These errors risk derogation cancellation, which may prompt other Member States to do the same. Thus, the European Commission taking over the derogation could simplify and reduce risks.
The European Commission serves Member States and should not interact with EU citizens. That means Member States will handle Union-wide derogations. No Union-wide derogation has been granted; hence no in-depth experience exists.
The European Commission will likely coordinate this derogation with one Member State. The manufacturer or Authorized Representative’s Member State is likely, but not guaranteed. The coordinating Member State can directly contact the device’s Notified Body.
Other Useful Standards
It’s well worth noting that guidelines and ISO standards are being formulated on how the environmental impact should be assessed for medical devices. But currently we are using crossover guidance from other industries and their applicable ISO standards to outline the way forward.
There is no telling at this stage whether the risk management and the quality management ISOs for medical devices will be updated with sustainability guidance or ISO standards that are currently in circulation. But it is safe to say it’s worthwhile for manufacturers to start familiarising and strategically planning around the guidance that is available.
Below is an overview of some other standards which may well be of interest and are also well used in the MedTech industry.
When is use of Article 59 appropriate?
Article 59 allows non-CE-marked compliance products to be sold in Europe if they are urgently needed. Manufacturers should understand that this isn’t an easy process.
Manufacturers must prepare for frequent, detailed post-market reporting and provide evidence comparable to CE Mark certification. If the derogation is leveraged to Union level, it will raise scrutiny and pressure on any certification procedure. In practice, the derogation should only be considered in conjunction with an ongoing CE mark certification at a Notified Body.
Clin-r+ recommendations
As a manufacturer, you should try to avoid legal actions against a notified body. It would be a much better strategy for someone else to do that on your behalf.
In this situation, we would recommend that you consider approaching the Member State where the notified body is based with an Article 59 derogation request. If that request is drafted well, this may make the authorities put pressure on the notified body to get their administrative processes in order, while you keep your relations with the notified body friendly.
Clin-r+ can assist with drafting this request. Should you have any questions or need professional assistance, CLIN-r+ has a wealth of experience to call upon. Get in touch!
