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In this Connect to Frankfurt session, Philipp Annecke, Junior Key Account Manager and Heinrich Martens, VP Regulatory Affairs of Fresenius Kabi (Bad Homburg, Germany) present guidances from the Medical Devices Regulation on clinical data evaluation for medical devices, and how manufacturers can select the right method and strategy for collecting post-market clinical follow-up data (PMCF) 

This extremely topical webinar addresses the challenge that the complex European Medical Device Regulation (MDR) poses for the entire industry, with a special focus on drug combination products and the requirements of Article 117.

Join Heinrich Martens, Vice Regulatory Affairs, Fresenius Kabi and Jonas Orf, Junior Key Account Manager, Fresenius Kabi as they shed light on the new requirements of MDR including stricter pre-market control, oversight of notified bodies, inclusion of products without medical purpose and rules on clinical data and clinical investigations.

They also provide an introduction to the drug combination ‘world’ within the context of MDR Article 117, the role of the Notified Body, fulfilment of the General Safety and Performance Requirements (GSPRs) and responsibilities and obligations of the manufacturer(s).

“In the MDD world that we had in the past, we had the essential requirements, which were similar to the GSPRs, but there was never anything about a Notified Body opinion, an additional approval step for the device that was required for a drug combination submission to the authority,” says Martens. “Which is totally different when you look now into Article 117.”

By watching this webinar, you will understand:
What is a combination product

The meaning of Article 117

The role and task of the Notified Body

Manufacturer responsibilities

Evidence and fulfilment of the GSPRs

Notified Body opinion