Be prepared for your medicinal product marketing authorisation approval
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.
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.
To improve the predictability and efficiency of TÜV SÜD’s assessments, you should submit a completed application for a Notified Body Opinion at least eight weeks prior to the submission of your documentation for assessment. The completed application should include all information as required in the Application Form for Article 117.
Provision of additional information as proposed below could streamline the application process: A draft of the instructions for use and/or a product description.
A description of the variation and the impact on the medical device part including references to the previously/initially obtained Notified Body Opinion. Identification of the applicable GSPR affected from the variation.
The completed application file can be submitted to your client manager or to our central mailbox for requests related to Article 117 (MDR) [email protected].
If you would like to register your interest into the service, prior to submission of the application form, please use our MDR enquiry form and submit the required information.
WHY CHOOSE TÜV SÜD?
As a Notified Body, TÜV SÜD has the capability to assess manufacturer documentation for all medical devices regarding each applicable GSPR. Our experts are dedicated to all class risk devices, with expertise ranging from the technical to the clinical aspects including the specific filed of medicinal substances.
TÜV SÜD is one of the world's leading Notified Bodies for the approval of medical devices. Our clients benefit from TÜV SÜD's technical, scientific and clinical expertise and its extensive international accreditations, including NRTL, INMETRO and the Medical Device Single Audit Program (MDSAP). Our experts contribute their expertise to numerous medical device standards development committees and medical device working groups around the world. These benefits considerably reduce the efforts involved in accessing international markets and time to market.
Be confident of medical device market approval
On May 5th 2017, the European commission has published a new regulation for medical devices.
Overcoming hazards in connected healthcare