DNV MEDCERT certification services

Challenges in medical device compliance 

In today’s highly regulated and innovation-driven healthcare environment, ensuring the safety, performance, and regulatory compliance of medical devices is more critical than ever. Manufacturers face increasing scrutiny from authorities, healthcare professionals, and patients alike.

With the EU Medical Device Regulation (MDR) in full effect, the role of a competent, efficient, and collaborative Notified Body has never been more vital. Whether you're launching a new product or maintaining compliance across a portfolio, having the right certification partner is essential for timely, safe, and successful market access.

How our medical device services support you  

DNV MEDCERT GmbH is a Notified Body (identification number: 0482) designated under EU MDR (2017/745). As part of the DNV Group, we specialize in conformity assessment and certification services for medical devices. 

We offer: 

• EU MDR conformity assessment and certification. 
• Quality management system certification (ISO 13485). 
• MDSAP certification.
• Technical documentation assessment. 
• Clinical assessments. 
• Post-market surveillance support. 
• Expert guidance throughout the regulatory lifecycle. 
• Certification services for legacy products transitioning from MDD. 

Our role is to help ensure that your devices meet stringent safety and performance requirements so that they can reach patients with confidence and integrity.