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EU MDR Article 59 and CE Marking for Medical Devices

Derogation from the Conformity Assessment Procedure

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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:

1. At least one Member State authorises a derogation for CE Marking and notifies the
European Commission;

2. The justification for that derogation is shared in full with the European Commission and
the other Member States;

3. The derogation is also shared with the European Commission and Member States, as well
as any result from surveillance and monitoring activities;

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4. 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;

5. 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:

1. 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;

2. The device must be of vital importance;

3. There must be no sufficient substitutes available;

4. There must be no indications of risks of the device for public health;

5. Derogations are only temporary. The timeline match the expected timeline for achieving
CE Marking;

6. 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.

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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.

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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.

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

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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!

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