Our Commitment to Notified Body Opinions under Article 117 of the MDR

TÜV Rheinland Italy is dedicated to the evaluation and issuance of Notified Body Opinions in compliance with Article 117 of Regulation (EU) 2017/745 (MDR).

Article 117 mandates that medical devices combined with medicinal products meet the General Safety and Performance Requirements (GSPR) outlined in Annex I of the MDR. To help our clients fulfill these legal obligations, TÜV Rheinland Italy delivers independent, thorough, and reliable assessments.

With a team of highly qualified experts and a proven track record in certifying medical devices under the MDR, we are fully equipped to support companies in their efforts to bring safe, effective, and compliant combination products to market.

Our extensive expertise in conducting Notified Body Opinions benefits companies in the pharmaceutical and medical device industries by addressing challenges unique to combination products, conducting detailed technical analyses, and providing reports with internationally recognized credibility.

Transparency and collaboration: We work closely with our clients, ensuring continuous dialogue throughout the service and its development.

Flexibility and Precision: We adapt to the specific needs of each client, offering rapid response times without compromising evaluation quality.

Recognized technical expertise: Our experts specialize in the evaluation of integrated medical devices.

• Consolidated experience: With decades of experience in medical device certification under the MDD/MDR frameworks, we provide industry-leading services.
• Transparency and reliability: Each project is managed with the highest care and attention to technical details.
• Global brand: Our international reputation is synonymous with quality and reliability.

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Contact us to learn more

We are ready to discuss your needs and provide the necessary support for your next project. Contact us today to discover how we can help you reach your Notified Body Opinion and ensure the compliance of your combination products.

E-mail: Chiara.Lanzarini@it.tuv.com

Website: www.tuv.com/italy/en/

Mobile: + 39 338 66 33 232

Direct office: + 39 02 939 687 431

Get in touch with us today for personalized advice and premium support in achieving your regulatory goals.