Medical device certification and conformity assessment

TÜV NORD provides independent medical device certification and conformity assessment services, enabling manufacturers to demonstrate compliance with applicable requirements such as ISO 13485 and the EU Medical Device Regulation (MDR).

Our certification services focus on confirming product safety, quality, and regulatory conformity through structured and standardized assessment and audit procedures.

TÜV NORD is an internationally recognized testing and certification service provider. We assess and certify the fulfilment of legal requirements and voluntary standards worldwide. Our auditors are experts in their field and work with a standardized methodology. This allows us to guarantee you neutrality, independence and continuous support.

Medical device certification and conformity assessment

ISO 13485, EN 46003

ISO 13485 is the current international quality management system (QMS) standard for the medical device industry, while EN 46003 is an obsolete European standard that was replaced by ISO 13485 in 2003.

ISO 13485, EN 46003

MDD (Medical Devices Directive)

The Medical Devices Directive (MDD), specifically 93/42/EEC, was the European Union's former regulatory framework for medical devices. It has been repealed and replaced by the more stringent Medical Device Regulation (MDR) (EU) 2017/745.

MDD (Medical Devices Directive)

MDR (Medical Devices Regulation)

The EU Medical Devices Regulation (MDR) is Regulation (EU) 2017/745, a set of rules that governs the production and distribution of medical devices within the European Union. It replaced the Medical Device Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD) to improve patient safety and device

MDR (Medical Devices Regulation)