Following the Commission Implementing Regulation published last week, the MDCG published a guidance this morning to layout common criteria for the renewal of Notified Body designations until 26 May 2021 – under the MDD regime.
The Guidance is addressed to the designating authorities, which should perform ”an appropriate assessment of the continuous competence of the notified body and its ability to accomplish the tasks for which it has been designated”. The document enlists the below points to be reviewed especially:
- assessment of relevant quality management system procedures, forms and records, in particular qualification criteria, procedures for selection and authorisation of persons involved in conformity assessment activities, procedures to ensure independence, objectivity and impartiality of the notified body’s activities;
- assessment of an appropriate number of the notified body’s reviews of the manufacturer’s technical documentation, including clinical evaluations;
- assessment of an appropriate number of the notified body’s personnel files;
- discussion of the results of the assessments of quality management documents and records with responsible personnel, including management responsible for the implementation and update of the quality management system as well as the notified body’s assessors responsible for product review, including clinical evaluation, final review and decision-making processes;
- review of the outcome of the most recent on-site surveillance assessments and observed audits as well as of recent extraordinary assessment activities conducted by the designating authority.
On-site audits are envisaged, and in exceptional circumstances alternative solutions are foreseen, further explained below.
The MDCG also provided guidance on ”appropriate activities performed by designating authorities over notified bodies in order to ensure an adequate level of surveillance” (audits, on-site assessments) in the circumstances of the current COVID-19 outbreak. In this respect, the MDCG proposes the below alternative measures:
- on-site surveillance assessments may be replaced by remote surveillance assessments using the most advanced available Information and Communication Technologies as deemed appropriate in accordance with Union legislation on information security and data protection;
- assessment of all relevant and required documents/records off-site.
Please find the full text of the Guidance by clicking here.
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