EMA: Updated Q&A on Combination Products
EMA has updated their „Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies regarding medicines used in combination with medical devices and consultation for certain medical devices“.
This Q&A document provides practical considerations concerning the application of the medical devices and the in vitro diagnostic medical devices regulations (MDR and IVDR) in the context of combinations of medicinal products with medical devices.
A new chapter 4 on lifecycle management has been introduced. It deals with changes after the initial marketing authorisation (MA).
The general principles with regard to device changes when used in combination are:
· Agreements between the marketing autorisation holder (MAH) and the device manufacturer must ensure effective communication and management of changes to the device component.
· The MAH must assess whether any device change may impact the delivery, quality, safety or efficacy of the medicinal product.
· If the change affects information registered in the MA dossier, a variation application must be submitted according to the EU Variations Guideline.
· Even if the registered information is not affected, a variation is still required when the change impacts delivery, quality, safety or efficacy of the medicine–device combination.
· No variation is needed only if the change neither affects registered information nor impacts delivery, quality, safety or efficacy, and the information is not required in the MA dossier.
A new or revised notified body opinion or for class I (excluding Im and Is), MAH’s GSPRs (General Safety and Performance Requirements) compliance statement is:
- required when a new device is introduced with an extension of MA or a variation
- expected when major changes are introduced to an existing device which may have a significant impact on the delivery or the quality, safety, or efficacy of the medicinal product, such as:
- change to its design
- addition or replacement of an integral device (or device part)
- change to its performance characteristics
- change to its intended purpose such as a different patient population and/or new user (e.g. home versus hospital setting) and/or new usability study, and/or significantly different instructions for use
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