EU Regulations

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 play a central role in the conformity assessment of medical devices and in vitro diagnostic devices under the EU MDR and IVDR. This guide explains when a Notified Body is required, how they are designated, what they assess, the conformity assessment process, and how manufacturers can prepare for certification.