Article 117 MDR - Notified Body Opinion

MDR Article 117 focuses on drug-device combination products governed primarily in Directive 2001/83/EC or Regulation (EC) No 726/2004.

The MDR requires marketing authorisation holders (MAH) to prove that the device part of a combination product is in compliance with the applicable GSPRs laid down in Annex I. If the device part is not CE marked, such proof can be furnished by means of a Notified Body Opinion (NBOp). This NBOp will then be included in the pharmaceutical company´s marketing authorisation application (MAA) submitted to the European Medicines Agency (EMA).

This webinar session explains the requirements of Article 117 and fulfil them successfully. It also gives some insights into the most common findings of recent NBOp assessments.

Date and time: Monday, 17 May 2021, 11.30 am (CEST)

Your speakers: Dr. Christiana Hofmann, Team Lead Non-Active Medical Devices / Article 117

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