EMA’s Committee on Advanced Therapies plans to establish medical devices focus group

The plan provides that the medical device focus group will be composed of CAT members, alternates, and experts with medical device competence.

Other key objectives of the work plan regarding the upcoming application of the MDR and IVDR include:

• Reflection on the need to revise and update CAT’s "Procedural advice on the evaluation of combined advanced therapy medicinal products and the consultation of Notified Bodies in accordance with Article 9 of Regulation (EC) No 1394/2007 (EMA/354858/2010)" in light of the MDR;
• Reflection on the collaboration with EMA on how to enhance regulatory support regarding medical devices and in vitro medical devices aspects of product development;
• Providing training to CAT members on medical devices and in vitro medical devices.

Other initiatives proposed in the work plan include the following:

• Revising guideline regarding the quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells;
• Developing guideline regarding the quality, non-clinical and clinical requirements for applications for clinical trials for Advanced Therapy Medicinal Products;
• Contributing to the development of guidance by EMA’S human medicines evaluation committee (CHMP) on the best use of standards for registries for regulatory purposes;
• Establishing working groups with the EMA’s committees on orphan drugs (COMP) and paediatrics (PDCO) to optimize interaction and output regarding the assessment of advanced therapy medicinal products for rare diseases and paediatrics.

Authored by Elisabethann Wright and Vicky Vlontzou