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Article 117

Be prepared for your medicinal product marketing authorisation approval

your challenges

The new Regulation 2017/745 (EU) on Medical Devices (MDR) imposes strict demands on medical device manufacturers, Notified Bodies, and extends the scope also to the pharmaceutical industry related to medicinal substances with an integral medical device. Article 117 of the MDR amends the 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. This is applicable for devices where the manufacturer’s EU declaration of conformity and the relevant EU certificate issued by a notified body are not available.

From 26 May 2021, new marketing authorisation applications for medicinal products with an integral medical device shall be accomplished by a notified body opinion report. During preparation steps towards the MDR, it is important to be informed about the requirements and deadlines to obtain a notified body opinion report for the device part of the medicinal product.

WHAT IS A NOTIFIED BODY OPINION?

A Notified Body Opinion is an assessment which provides a statement on the conformity of the device part with the relevant GSPR as set out in Annex I of the MDR. The documentation on conformity with the GSPR must include manufacturers assessment on the applicability of the respective GSPR. Test reports, risk management reports, clinical evaluation, biological evaluations and other reports are to be included in the documentation to provide objective evidence on conformity of an applicable GSPR. The documentation is assessed by a MDR-designated Notified Body, for suitability of a device for its intended purpose, considering complexity of the device, relevant patient characteristics and the clinical setting. Having a MDR- designated Notified Body assess your documentation provides an independent report on the technical documentation following the legislative framework.

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