target group

Manufacturers of combination products, employees in regulatory affairs, responsible persons according to Art. 15 EU-MDR and device developers.

content

The EU-MDR also has an impact on the manufacturers of combination products ("drug device combinations"). Article 117 changes Annex I, Item 12 of Section 3.2 of the Medicines Directive 2001/83/EC. It said: "Where applicable and if needed, a CE marking which is required by community legislation on medical devices shall be provided." This text is now being modified and requires a mandatory CE certificate for the device component of the combination product. If this is not available, a statement from a notified body must be obtained. In the seminar, the importance of this change for manufacturers of combination products will be discussed. More recent guidance documents from the European Medicines Agency and the documentation requirements for obtaining the opinion of the notified body are presented. The consequences for the cooperation between drug manufacturers and medical device manufacturers are discussed.

topic overview

  • Importance of Article 117 EU-MDR for approval
  • Modification of MPD 2001/83/EC
  • EMA Definition of Combination Products (DDCs)
  • Notified Body Opinion
  • Technical documentation requirements
  • Impact on timelines for approval

previous knowledge

Recommended in the area of regulatory affairs.

KONTAKT:
Max-Planck-Straße 17,  Tuttlingen
Beruflichen Bildungsstätte Tuttlingen

 

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