New MDCG Position Paper on Management of SSCP and SSP in EUDAMED

The MDCG has published a brief Position Paper concerning responsibility for the management of summary of safety and clinical performance (SSCP) and the summary of safety and performance (SSP) following their upload to EUDAMED. Until now, Article 32.1 of the MDR imposed responsibility for uploading SSCPs and SSPs on the notified body.

The Position Paper advises manufacturers to upload SSCP and SSP summaries as soon as possible and no later than 27 February 2027.

The change in responsibility for which the Position Paper provides appears to revise the related provisions of Article 32.1 of the MDR. It is unclear where the legal basis for this revision could be identified.