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?
- Introduction to Article 117 & Notified Body opinion
- Selecting the right Notified Body
- Engaging with the selected Notified Body
- Best practices in documentation
After completing her pharmacy degree with specialization in formulation development, Susanne worked for 11 years in the pharmaceutical industry. Her experience includes upstream and downstream processing in bacterial cell culture and ATMP (cell lines) production under GMP conditions, formulation development for large molecules (plasmid DNA and proteins) including lyophilization, analytical techniques used for DNA and proteins, and writing CMC part of registration dossiers. Before joining Venn Life Sciences, Susanne worked for over 5 years at a notified body (BSI). There she was responsible for reviewing medicinal dossiers for device-drug combinations, performing consultations for these device-drug combinations with national competent authorities for small molecules and EMA for human blood derivatives or recombinant products as well as reviewing technical files for IVF products and organ preservation solutions (level III reviewer for NBOG codes SMDS1001, SMDS1008, SMDS1212). Additionally, she provided training on drug-device combinations falling under article 117 of the MDR and devices falling under rule 14 (device-drug combination devices) and rule 21 (substance-based devices) of the MDR.
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