The European Medicines Agency (EMA) has published the first of a series of guidance documents to help applicants prepare for the implementation of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The involvement of a Notified Body (NB) in a medicinal product with an integral medical device is the focus of the first EMA guidance related to the new European Union (EU) MDR.
The questions and answers (Q&A) document, which was developed by the EMA, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) and European Commission (EC), relates to the implementation of Article 117 of the MDR. From 26th May 2020, MDR will require a marketing dossier for a medicinal product with an integral medical device to include the results of the NB-issued assessment of conformity or relevant certificate so that the manufacturer can affix CE marking to the device. The requirement will be implemented under Article 117 of the regulation. The EMA stated that “approximately one in four centrally authorised medicines includes a medical device component, and the majority of these involve an integral device.”
Question 3 of the Q&A document explains the impact Article 117 will have on new marketing authorisation applications, which includes a table that summarises MDR-related changes for applications of medical products with integral medical devices.
The Q&A guidance document also outlines that the new requirement will only apply to applications covered by the guidance that were submitted from 26th May 2020, rather than prior to this date, and EMA’s recommendation for applicants to submit the required documentation as part of the initial application.
The MDR and IVDR will come into full effect in May 2020 and 2022, respectively. The EC have updated the MDR/IVDR rolling plan on the implementing acts and actions required prior to the enactment of the two new regulations. Revisions showed an increase in the number of applications receiving NB designation against MDR and IVDR. However, NB availability and readiness remain concerns for industry, and the possibility of a no-deal Brexit adds further concern.
To read more about the first guidance on new rules for certain medical devices, please click here.