Module 1 2021

30/06/2021

Article 117 medical device regulation Medical Device Regulation: came into force 26 May 2021

Article 117 of the EU MDR is about the drug-device combination products. The objective of Article 117 of the EU MDR is to involve the right stakeholders in the review process of the device by Notiffied Body (NB) and to also meet the expectations of the EMA and/or National Competent Auhtorities: -the MAA dossier should include results of the assessment of conformity or the relevant certificate issued by a notified body needed to affix a CE marling -an opinion on the conformity of the device part issued by a notified body

The Organisation for Professionals in Regulatory Affairs

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Strategic Options RMS, CMSs, Rapporteur, (Co)-Rapporteur

 Based on Regulatory, Strategic and commercial reasons  Availability of RMS in DCP • Where they supportive of product/dossier scientific advice • Expertise of RMS for certain type of Products • Availability of Slot;  For MRP, RMS is where dossier was filed and approved nationally  Centralised Procedure – (Co-)Rapporteur Appointed • No Influence of Applicant • Supportive of product dossier during scientific Advice; Should you try to influence the choice of Rapporteur ?

The Organisation for Professionals in Regulatory Affairs

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