Handling of Changes to Medical Device Products for approved Combination Products

Recommendation

23-25 April 2024

Cleaning Validation AND Pre-Course Workshop: Impact of Annex 1 Revision on Cleaning Validation - Live Online Training

In EMA updates Guidance for Post-Authorization Activities you could read about a question-and-answer document from the European Medicines Agency (EMA), describing certain issues concerning the handling of changes after approval ("variations"). This document has been updated again. The topic of changes to medical devices after the approval of "combination products" has now been added.

The document refers to chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 ('the Variations Regulation') concerning changes to medical devices and generally to the Guideline "Details of the various categories of variations, on the operation of the procedures (classification B.IV.1). Depending on the change the "variation" can be a Type IA(IN), IB or II. With a reference to the short periods of "variations" the document clarifies that if the "variation" is a medical device product added to the medicinal product not building an integral product with it, the documentation for the CE marking must also be submitted along with the change.

Please also see "Classification of changes: questions and answers" on the EMA website.