EU Regulations

Ensuring safety and efficacy is paramount for medical devices. Manufacturers aiming to market their products within the European Union must navigate a complex regulatory landscape. One of the most critical aspects of this process is obtaining CE marking—a declaration that a product complies with all relevant EU legislation. Central to this pathway is the involvement of Notified Bodies (NBs).

Medical device manufacturers aiming to market their products in the European Union must navigate a complex regulatory landscape. At the heart of this framework is the EU Medical Device Regulation (MDR) 2017/745, which replaced the Medical Device Directive (MDD). One of the most critical components of this regulation is the General Safety and Performance Requirements (GSPRs), outlined in Annex I of the MDR.

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Understand medical device packaging validation, including ISO 11607 requirements, sterile barrier systems, seal integrity, ageing, distribution testing and packaging process validation.

Medical device validation provides documented evidence that devices, manufacturing processes and associated systems consistently meet their intended requirements and are suitable for their intended use.

From design verification and validation through to process validation, cleaning, sterilisation, packaging and software, manufacturers must determine which activities require validation and establish objective evidence that applicable regulatory and quality requirements have been met.

This guide explains the key principles of medical device verification and validation, the requirements of the EU MDR, UK MDR and ISO 13485, and how manufacturers can develop a risk-based validation strategy throughout the medical device lifecycle.

Medical device cleaning validation provides documented evidence that a defined cleaning process can consistently reduce contaminants and residues to predetermined acceptable levels without adversely affecting device safety or performance.

Cleaning validation may be required during medical device manufacturing and is particularly important for reusable devices that must be safely cleaned and reprocessed between uses.

This guide explains the regulatory requirements for medical device cleaning validation, applicable standards, acceptance criteria, worst-case selection, test methods, validation protocols and the evidence manufacturers need to demonstrate an effective and reproducible cleaning process.

Medical device and IVD labelling plays a critical role in patient safety, product traceability and regulatory compliance. This guide explains the labelling requirements under the EU Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746), including mandatory label information, Instructions for Use (IFUs), UDI, symbols, language requirements and best practices for maintaining compliant labels throughout the product lifecycle.

Notified Bodies are independent organisations designated by EU Member States to assess whether medical devices and IVDs comply with the requirements of the EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR). Learn how Notified Bodies conduct conformity assessments, review Technical Documentation, perform quality management system audits, issue CE certificates and support manufacturers throughout the certification process.