Notified Body Requirements for Drug-Device Combinations: Demystifying Article 117
The involvement of a notified body is an essential aspect of the regulatory process for combination products covered by Article 117, as it helps to ensure that the device component of your combination product is safe, effective, and compliant with applicable regulations.
On 26 May 2021, the medical device regulation (MDR) took effect. Article 117 of the MDR amends Directive 2001/83/EC, point 12 of Section 3.2 and requests for (single) integral products the involvement of a Notified Body to assess the conformity of the device part with the relevant general safety and performance requirements (GSPR) of Annex I.
Therefore, from 26 May 2021, new marketing authorization applications for medicinal products with an integral medical device must include a notified body opinion report.
But what do you need exactly to receive this Notified Body opinion report?
Key Learnings:
- Introduction to Article 117 & Notified Body opinion
- Selecting the right Notified Body
- Engaging with the selected Notified Body
- Best practices in documentation
You can view this webinar from your computer, tablet or mobile phone.
On 26 May 2021, the medical device regulation (MDR) took effect. Article 117 of the MDR amends Directive 2001/83/EC, point 12 of Section 3.2 and requests for (single) integral products the involvement of a Notified Body to assess the conformity of the device part with the relevant general safety and performance requirements (GSPR) of Annex I.
Therefore, from 26 May 2021, new marketing authorization applications for medicinal products with an integral medical device must include a notified body opinion report.
But what do you need exactly to receive this Notified Body opinion report?
Key Learnings:
- Introduction to Article 117 & Notified Body opinion
- Selecting the right Notified Body
- Engaging with the selected Notified Body
- Best practices in documentation
You can view this webinar from your computer, tablet or mobile phone.
