COVID-19 drives EC to change rules on notified body designations

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Dive Brief:

  • The European Commission has cleared member states to deviate from normal procedures for overseeing notified bodies during the COVID-19 pandemic, per an amendment to implementing regulation published Tuesday.
  • The Commission said member states can renew designations under the outgoing device regulations without performing the on-site assessment required in normal times. The legislation also relaxes the rules on surveillance and monitoring.
  • The EC published the law on the same day as guidelines outlining when devices cleared for use by national authorities without conformity assessments can be made available across the European Union.

Dive Insight:

The one-year delay in the date of application of the Medical Device Regulation means notified bodies designated under the outgoing regime will remain relevant until May 2021. Designations last up to five years under legislation passed in 2013, suggesting some notified bodies could lose the authority to assess devices during the one-year extension unless they get their clearances renewed.

COVID-19 is creating barriers to the renewal of designations. The 2013 legislation details a seven-step procedure for designating notified bodies that includes on-site assessments. The renewal process follows the same procedure as initial designations.

In light of the problems the time of limited travel and in-person contact creates, the Commission opted to clear member states to “renew a designation as notified body without having recourse to the procedures” set out in the 2013 legislation. The Commission still expects member states to verify a notified body is compliant with the rules and able to perform its tasks.

Member states that renew designations without following the normal procedures must let the Commission know and provide “substantive reasons” for their actions. The Commission may ask for the findings of the assessment that supported the decision. With MDR due to come into force in May 2021, designations renewed under the emergency procedure will expire automatically next year.

The Commission enacted the change in legislation that also addressed how member states should monitor notified bodies during the coronavirus crisis. The 2013 law mandates on-site assessments every 12 to 18 months, depending on the size of the notified body.

As it is currently impossible to perform such assessments, the Commission is asking member states to “carry out any measures to ensure an adequate level of surveillance that remain possible.” The Commission also wants member states to assess an “appropriate number of the notified body’s reviews of the manufacturer’s technical documentation.”

Details of the revised rules went live around the same time as Commission guidelines on EU-wide medical device derogations. The outgoing and incoming medical device rules permit member states to allow the use of devices that are yet to undergo conformity assessments in the interest of health or safety. MDR empowers the Commission to extend national clearances to cover the EU.

The guidelines published this week explain how the process will work in practice. In assessing whether an EU-wide clearance is appropriate, the Commission will first work with the Medical Device Coordination Group to establish the relevance of extending the geographic scope of a decision. The final decision will rest on whether a device “is of vital importance” and the availability of suitable alternatives.