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What is MDR Article 117
Medicinal substances are often combined with a medical device intended for delivery. These devices include pre-filled syringes, pre-filled pens, nebulizers pre-charged with a specific medicinal product etc. The EU’s Medical Device Regulation (MDR) introduces MDR Article 117 with the purpose is to ensure compliance of such devices with the relevant general safety and performance requirements set out in Annex I of the MDR regulation. Manufacturers are required to involve a Notified Body such as TÜV SÜD to assess manufacturers documentation / dossier and to confirm such product compliance to GSPRs.
From 26 May 2021, new marketing authorization applications for medicinal products with an integral medical device shall be accomplished by a notified body opinion report, where CE mark or a declaration of conformity for the medical device is missing. During preparation steps towards marketing application, 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.
Notified Body Opinion: Key Steps for Manufacturers
A Notified Body Opinion is a report which documents the result of the assessment on the device's conformity with the relevant GSPR as set out in Annex I of the MDR. Manufacturer’s documentation is assessed by an MDR-designated Notified Body such as TÜV SÜD, for suitability of a device for its intended purpose, considering complexity of the device, relevant patient characteristics and the clinical setting. Having your documentation assessed by an MDR-designated Notified Body provides an independent report on the technical documentation following the legislative framework.
From 26 May 2021, new marketing authorization applications for medicinal products with an integral medical device shall be accomplished by a notified body opinion report, where CE mark or a declaration of conformity for the medical device is missing. During preparation steps towards marketing application, 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.
Notified Body Opinion: Key Steps for Manufacturers
A Notified Body Opinion is a report which documents the result of the assessment on the device's conformity with the relevant GSPR as set out in Annex I of the MDR. Manufacturer’s documentation is assessed by an MDR-designated Notified Body such as TÜV SÜD, for suitability of a device for its intended purpose, considering complexity of the device, relevant patient characteristics and the clinical setting. Having your documentation assessed by an MDR-designated Notified Body provides an independent report on the technical documentation following the legislative framework.
Your Submission to TÜV SÜD
Request of a New Notified Body Opinion
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 the assessment. The completed application should include all information as required in the Application Form for Article 117 of MDR.
Provision of additional information such as instruction for use and/or a product description could streamline the application process.
The completed application file can be submitted to your client manager or to our central mailbox for requests related to Article 117 (MDR).
How TÜV SÜD Can Help You with MDR Article 117
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 risk class devices, with expertise ranging from the technical to the clinical aspects including the specific field of medicinal substances. We have experienced experts in your local markets who can speak in your language.
TÜV SÜD is one of the world's leading Notified Bodies for the approval of medical devices. Our clients benefit from our technical, scientific and clinical expertise and our extensive international accreditations.
Our experts contribute their expertise to numerous medical device standards development committees and medical device working groups around the world.
Our experts are dedicated to all risk class devices, with expertise ranging from the technical to the clinical aspects including the specific field of medicinal substances. We have experienced experts in your local markets who can speak in your language.
TÜV SÜD is one of the world's leading Notified Bodies for the approval of medical devices. Our clients benefit from our technical, scientific and clinical expertise and our extensive international accreditations.
Our experts contribute their expertise to numerous medical device standards development committees and medical device working groups around the world.
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