Commission Implementing Regulation on NB designations + Commission Communication on Union-wide derogations

Our Library of Documents is richer for two more documents addressing the COVID-19 pandemic:

  • Commission Implementing Regulation: renewal of designations and the surveillance and monitoring of notified bodies

As an additional measure to address the COVID-19 outbreak, the European Commission touched upon the case of all the those Notified Bodies (NBs), whose designations under the Medical Device Directives would expire in the upcoming year – in view of the new Regulation amending the MDR and postponing its date of application to 26 May next year. For this reason and only for the period between 19 May 2020-25 May 2021, the Commission is giving the option to the Designating Authority to renew the designation of NBs under the Directives without following procedures of Article 3 of the Regulation 920/2013 (which governs the NB designation under the Directives).

The Implementing Regulations also amends section on surveillance of NBs and provides for alternative solutions to the Designating Authority in view of the exceptional circumstances relating to the COVID-19.

  • Commission Communication on Aricle 59 of the MDR (Union-wide derogations)

Article 59 of the MDR empowers the European Commission to extend a national derogation – in exceptional circumstances & for limited time of 6 months & to protect public health – granted and notified by the Competent Authority of an EU Member State to the whole Union territory.

The new Regulation amending the MDR date of application enlarged this Article 59, which allows the European Commission (EC) to trigger such Union-wide derogation already under the current MDD system. In the new Communication, the Commission puts forward the guidance how will the process of adopting such an Union-wide derogation look like:

1. The EC will consult through the MDCG with the EU Member States to establish whether the derogation can be qualified of Union-relevance;

2. The EC will verify whether procedural requirements (5 are enlisted in the Communication) has been met;

3. The EC will determine whether adopting a Union-wide derogation in the case at hand would be duly justified, based on 5 elements included in the Communication.

4. If the above is affirmative, the EC will issue the Implementing Act and grant the Union-wide derogation.

On duly justified imperative grounds of urgency relating to the health and safety of humans, the EC can adopt immediately applicable implementing acts without its prior submission to the relevant Comitology committee. Nevertheless, when submitted (max 14 days) and if the Committee delivers a negative opinion, the Commission will immediately repeal the implementing act.

Check for icons “EUROPEAN COMMISSION” and “NOTIFIED BODY” at MDlaw Library of documents and find the above and other related documents.

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