EC eases rules for renewing notified body designations, explains process for EU-wide derogations

  • July 14, 2020

The move comes as the Commission works to realign the various components of its regulatory framework for medical devices to accommodate the one-year MDR delay necessitated by the coronavirus disease (COVID-19) pandemic and the two-year Eudamed delay announced last year.

The Commission also released guidelines on in May explaining the process and requirements for adopting EU-wide derogations for medical devices under MDR.  In delaying MDR, EU authorities adopted provisions to allow for EU-wide derogations for medical devices prior to the full application of MDR as a means of addressing potential device shortages amid the pandemic.

Designation renewals

According to the Commission, “a significant number” of notified bodies’ designations under the Medical Device Directives (MDD) and Active Implantable Medical Device Directives (AIMDD) are set to expire in the intervening year.  “Without valid designation, those notified bodies would no longer be able to issue certificates, and ensure their continuous validity,” the Commission writes, adding that it is “essential that notified bodies … are able to continue to operate until the new regulatory framework for medical devices under [MDR] becomes applicable.”  However, due to the disruption caused by the pandemic, the on-site assessments and audits typically required for renewing a designation cannot be carried out.

As such, the Commission says it will allow designating authorities to deviate from normal procedures to renew designations under the directives until MDR takes effect.  “This should allow designating authorities, in the context of the COVID-19 pandemic and the associated public health crisis, to derogate from the procedures … in order to guarantee the smooth and timely renewal of a designation before its expiry,” the Commission writes.

While allowing designating authorities to bypass the in-person components of their assessments, the Commission says the assessment should still verify a notified body’s “continuous competence” and include a review of the body’s documents and activities.  The Commission says the flexibilities only apply to renewing designations for notified bodies that have previously gone through the designation process and should be done before their designations expire.

EU-wide derogations

In its guideline on EU-wide derogations, the Commission explains the procedural and justification requirements for adopting EU-wide derogations and outlines the adoption process and other conditions for making such derogations.  “Union-wide derogations should be regarded as a measure of last resort, only to be considered in exceptional cases to ensure patient health or safety or to protect public health,” the Commission writes.

To make an EU-wide derogation for a medical device, the Commission says that at least one national derogation must be granted and notified to the Commission and that the justifications, parameters and technical documentation related to each derogation must be provided to the Commission and all other member states.

The Commission adds that it may impose stricter conditions on devices subject to EU-wide derogations than those established by a national derogation and that it may consider additional information including comments submitted by member states or the Medical Device Coordination Group in deciding to adopt an EU-wide derogation.

REFERENCE:  Regulatory Focus (RAPS); 20 MAY 2020; Michael Mezher

Leave a Comment