EU Regulation (EU) 2017/745 (MDR) - Medical Device Regulation

What it says

The Medical Device Regulation sets requirements for placing medical devices on the EU market, including risk-based classification, conformity assessment, often involving a notified body, technical documentation, clinical evaluation, unique device identification, post-market surveillance and vigilance, and a requirement that manufacturers have a quality management system. Manufacturers must also have a person responsible for regulatory compliance.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• It replaced the earlier directives with a more demanding framework, particularly for clinical evidence and post-market activities.
• The quality management system requirement connects to ISO 13485, which is commonly used to demonstrate it.
• Economic operators, such as authorised representatives and importers, have defined obligations as well.

What inspectors look for

• Whether devices are correctly classified and conformity assessment is complete.
• Whether technical documentation and clinical evaluation are current.
• Whether post-market surveillance and vigilance processes operate and feed back into the system.

Related regulations