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Medical Device Regulation
CE Certification MDR (EU) 2017/745
Expectations for the safety and quality of medical devices are continuing to rise worldwide. At the same time, regulatory requirements are becoming increasingly complex and stringent year by year. As products become more advanced and digitalized, addressing privacy and cybersecurity has also become an essential part of compliance.
Under the MDR, particular emphasis is placed on clinical evaluation, strengthened traceability, and greater transparency for patients. As a result, market access requirements for the European market have become more stringent than before, requiring not only manufacturers but also importers, distributors, and notified bodies to meet a higher level of compliance.
Medical device manufacturers are responsible for placing products on the market appropriately while ensuring the safety of end users, including patients. To achieve this, it is essential to demonstrate that innovative medical devices function safely and effectively and to ensure steady compliance with European regulatory requirements.
As a notified body providing the conformity assessments required for access to the EU market, DEKRA works with customers to build a reliable path toward certification. Drawing on extensive expertise and experience, we help simplify complex regulatory requirements and strongly support our customers in achieving smooth market entry.
Medical device manufacturers are responsible for placing products on the market appropriately while ensuring the safety of end users, including patients. To achieve this, it is essential to demonstrate that innovative medical devices function safely and effectively and to ensure steady compliance with European regulatory requirements.
As a notified body providing the conformity assessments required for access to the EU market, DEKRA works with customers to build a reliable path toward certification. Drawing on extensive expertise and experience, we help simplify complex regulatory requirements and strongly support our customers in achieving smooth market entry.
DEKRA’s strengths:
• DEKRA has two notified bodies for the EU Medical Device Regulation (MDR 2017/745)—DEKRA Certification GmbH (NB 0124) and DEKRA Certification B.V. (NB 0344)—enabling us to provide flexible certification services tailored to a wide range of products and customer needs.
• With this structure, DEKRA serves as a highly reliable partner in medical device certification, offering comprehensive support aligned with each customer’s product characteristics and market strategy. Another key strength unique to DEKRA is our ability to respond across a broad range of medical device fields through our global network of experts.
To market medical devices internationally, it is necessary to accurately understand complex regulatory requirements and to ensure compliance with the standards and regulations of each country and region.
DEKRA’s medical device certification team brings extensive global expertise across a wide range of medical device fields. Even in an increasingly complex regulatory environment, we propose the most suitable certification approach for each customer’s individual situation and support smooth entry into the European market with proven professionalism and experience.