Medical Device Glossary

CE marking is a mandatory conformity mark for medical devices placed on the EU market. It indicates that a device meets the applicable requirements of the EU MDR. For all Class IIa, IIb and III devices, and certain Class I devices (sterile, measuring function, or reusable surgical instruments), CE marking requires the involvement of a Notified Body. CE marking is a declaration of regulatory compliance, not a quality endorsement.

Source: Regulation (EU) 2017/745

A Clinical Evaluation is a systematic and planned process for continuously generating, collecting, analysing and assessing clinical data pertaining to a medical device, to verify its safety and performance throughout its lifecycle. It is not a one-time activity, it must be updated regularly as new post-market data becomes available. Under EU MDR, the requirements for clinical evaluation are substantially more rigorous than under the previous MDD, and insufficient clinical evidence is one of the most common causes of Notified Body delays.

Source: Regulation (EU) 2017/745, MDCG 2020-6

CAPA is a structured process for identifying, investigating and resolving the root causes of quality events such as non-conformances, complaints and audit findings. A Corrective Action addresses an existing problem; a Preventive Action addresses a potential problem before it occurs. An effective CAPA system is one of the most scrutinised elements of a QMS during audits.

Source: ISO 13485:2016

The EU Medical Device Regulation (Regulation 2017/745) replaced the Medical Device Directive (MDD 93/42/EEC) and introduced significantly more stringent requirements for medical devices placed on the EU market, including strengthened clinical evaluation requirements and the introduction of the EUDAMED database. All devices require CE marking under EU MDR to be legally placed on the EU market.

Source: Regulation (EU) 2017/745

ISO 13485 is the international standard specifying requirements for a Quality Management System (QMS) for medical device organisations. Unlike ISO 9001, ISO 13485 focuses specifically on regulatory compliance rather than continuous improvement. Certification of the QMS is required for CE marking of Class IIa, IIb and III devices under EU MDR, and for equivalent device classes under UK MDR 2002.

Source: ISO 13485:2016

A Notified Body is an organisation designated by an EU member state to assess the conformity of certain products, including Class IIa, IIb and III medical devices before they are placed on the EU market. Notified Bodies (NB) conduct QMS audits, review Technical Files and issue CE certificates.

Source: Regulation (EU) 2017/745, NANDO database (European Commission)

Post-Market Surveillance is the ongoing process of collecting, recording and analysing data from devices already on the market to identify issues, trends or risks that were not apparent during pre-market development. Under EU MDR, PMS is a legal obligation for all device manufacturers and must be integrated into the QMS. Manufacturers of Class IIa, IIb and III devices are additionally required to produce a Periodic Safety Update Report (PSUR), while Class III and implantable devices also require a Summary of Safety and Clinical Performance (SSCP).

Source: Regulation (EU) 2017/745, MDCG 2022-21, MDCG 2019-9

A Quality Management System (QMS) is a formalised framework of policies, procedures and records that defines how an organisation manages quality across its activities. All medical device manufacturers are legally required to have a QMS in place, regardless of device class. For manufacturers of Class IIa, IIb and III devices, the QMS must be third-party certified for market access in the UK and EU. For Class I devices, self-certification is adequate, however third-party certification is widely considered best practice.

Source: Regulation (EU) 2017/745, ISO 13485

Risk management is the systematic process of identifying, evaluating, controlling and monitoring risks associated with a medical device throughout its lifecycle. Compliance with ISO 14971 is required under both EU MDR and ISO 13485, and a Risk Management File must be maintained for each device. Risk management is not a one-time exercise, it is a living process that must be updated as new information becomes available throughout the product lifecycle.

Source: ISO 14971

A Technical File (EU MDD term, or Technical Documentation under EU MDR) is the collection of documents that demonstrates a medical device's conformity with applicable regulatory requirements. It encompasses device description, design and manufacturing information, risk management documentation, clinical evaluation, labelling and post-market surveillance plans. The Technical File must be compiled and maintained throughout the device's lifecycle.

Source: Regulation (EU) 2017/745