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Welcome to Day 2 and Session 5: EU Medical Device Regulation (MDR): Implication to Integral and Non-Integral (Co-Packaged Products)
Session Chair(s)
James Wabby, MHS
Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
AbbVie, United States
Article 117 of the Medical Device Regulation 2017/745 amended Annex I to Directive 2001/83/EC, point 12 of section 3.2), and introduces a new requirement for notified body involvement in a medicinal product with an integral medical device. The marketing authorization dossier for a medicinal product with an integral medical device is expected to include the results of the assessment of conformity for the medical device component to the General Safety and Performance Requirements (GSPRs) laid down in Annex I of the Regulation (i.e. the declaration of conformity or the relevant certificate issued by a notified body). The session will provide an overview of current challenges and opportunities including a panel discussion:EMA representative, Notified Body Representatives, and Industry:
- Overall Impact to Drug Delivery Devices including Combined Advanced Therapy Medicinal Products (cATMP)
- Application of Article 117 as Article 2(1)(d) of Regulation (EC) No 1394/2007 drives the combined advanced therapy medicinal products regulatory pathway process
- Notified Submission process to obtain an opinion on the conformity of the device constituent part (e.g. Integral and Non-Integral)
- Lifecycle Management and variation process for drug delivery devices
Learning Objective : - Analyze regulatory expectations and industry challenges in complying with Article 117
- Discuss considerations for regulatory communications with NB
- Recognize expectations on the variation process with NB and EMA
- Identify differences and similarities between the EU MDR and combined advanced therapy medicinal products as defined under Article 2(1)(d) of Regulation (EC) No 1394/2007
- Discuss the latest information and processes from EMA and NB
Speaker(s)
Industry perspective: Overall Impact to Drug Delivery Devices including Combined Advanced Therapy Medicinal Products and impact of Article 117 and No. 1394/2007
Kimberly Trautman, MS
Trautman International Services, United States
Managing Director
EMA perspective: Overall Impact to Drug Delivery Devices including Combined Advanced Therapy Medicinal Products and impact of Article 117 and No. 1394/2007
Armin Ritzhaupt, PhD, MPH
European Medicines Agency, Netherlands
Scientific Administrator
Notified body submission process to obtain an opinion on the conformity of the device constituent part
Susanne Fornero, PharmD, PhD
BSI, Netherlands
Medicinal Expert
Lifecycle Management for Drug Delivery Devices
Julia Frese, MBA
TÜV SÜD , Germany
Department Manager Centre of Combination Products
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