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Update of Q&A list for the submission of variations for human medicinal products

The consequence of the new Medical Device Regulation (EU) 2017/745 was update of CMDh Question & Answer document for Variations in May 2022. The updated was number 4.12. within Q&A document, which concerns update of a dossier before a RUP/MRP/duplicate application. Added was the following wording: “new or updated documentation for the medical device confirming compliance with relevant general safety and performance requirements set out in the Medical Device Regulation (EU) 2017/745 (EC declaration of conformity, CE-certificate, or Notified body opinion as applicable)”. Meaning that during update of dossier for medicinal product part dedicated to medical device must be aligned with new Medical Device Regulation (EU) 2017/745. The exact Q&A information is provided herewith.

Question 4.12.:

If it is intended to update a dossier in preparation of a RUP/MRP/duplicate application to conform to the current legislation, how can this update of the dossier be submitted?

Answer:

When updating a dossier for a RUP/MRP/duplicate application in order to conform to the current legislation all changes for the update of the dossier, including changes or addition of Braille, User Test, Environmental Risk Assessment, summary of pharmacovigilance system, RMP, QPs declaration, updated confirmatory stability data, new or updated documentation for the medical device confirming compliance with relevant general safety and performance requirements set out in the Medical Device Regulation (EU) 2017/745 (EC declaration of conformity, CE-certificate, or Notified body opinion as applicable), updated Clinical and Non-clinical overviews and summaries or Expert reports based on already submitted and approved clinical and preclinical data, may be submitted as one single variation of type II under category C.I.z, rather than a grouped application.

In case new data are submitted, for example the addition of literature references, separate variations for Modules 4 and 5 should be submitted. A grouped variation might be feasible if justifiable and agreed by the competent authority.

 

Reference:

Q&A – List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008

CMDh_132_2009_Rev58_TC_QA_on_Variations.pdf (hma.eu)