PHARMALEX SPAIN, S.L.U.

21st September

10:00 – 12:00

Farmaforum Workshop Room 2

Regulatory framework for drug and medical device combinations

Speakers:

Javier Varela Cantalapiedra, Senior Manager Medical Devices/IVD

Gonzalo Arévalo Arribas, Senior Manager Medical Devices/IVD

Summary:

The workshop will consist of a review of the regulatory framework applicable to combination products of medicinal products (Directive 2001/83/EC) and medical devices (Regulation (EU) 2017/745 (MDR)), especially to the application of Article 117 of the MDR.

In addition, a detailed analysis of the MDCG 2022-5, “Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices”, will be carried out to clarify important concepts and terms that have not been defined in the MDR, in order to facilitate decision-making by manufacturers or holders of these products when establishing the classification of the product as a medicinal product or medical device, and, therefore, to know which legislation applies to them in each case.

Finally, the EMA guideline EMA/CHMP/QWP/BWP/259165/2019, “Guideline on quality documentation for medicinal products when used with a medical device” will be analyzed in detail and it will be explained in a practical way, which information and documentation of the medical device must be submitted, and in which sections of the drug authorization dossier (eCTD) this information must be included.