Webinar
Implementation of EU MDR Article 117
| On-Demand | 1 Hour | Your Desk! |
| On-Demand | 1 Hour | Your Desk! |
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Tiina Riihimäki, PhDDirector, Head of Medical Devices / IVDs, Nordics, PharmaLex |
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Theresa JearyPrincipal Technical Specialist, Medicinal & Biologics,BSI |
The EU MDR 2017/745 Article 117 introduced requirements for device part of an integral drug-device combination to comply with applicable MDR Annex I requirements, so called GSPRs (General Safety and Performance Requirements). Compliance to GSPRs of higher risk class device parts such as pre-filled syringe, autoinjector, inhaler will require involvement of Notified Bodies to obtain a Notified Body Opinion (NBOp). An NBOp is an essential part of the marketing authorization dossier of a drug product.
This means that what may have previously been considered as a contain-closure of a medicinal product, now needs to be considered as if it were a medical device and technical documentation must be prepared and submitted to a Notified Body for review. This presents a challenge for the pharmaceutical industry who may lack medical device expertise and may not be familiar with the EU MDR and the GSPRs.
In this webinar, Pharmalex will explain the regulatory requirement and provide some key learnings from the first few years of experience with these types of submissions. We will also hear from a leading Notified Body expert to understand better NBOp submission process and related expectations, and to highlight some of the common issues they see with submissions for Notified Body Opinions.