Plain-English definitions of the terms you meet when preparing a technical file for EU MDR, IVDR and UKCA. Each entry points to the relevant part of the regulation where it helps.

A

Annex II and Annex III

The two annexes of the EU MDR that set out what a technical file must contain. Annex II covers the technical documentation itself: device description, labelling, design and manufacturing information, GSPR, benefit-risk and risk management, and verification and validation. Annex III covers the technical documentation on post-market surveillance. EU MDR technical file guide

Authorised representative

A person or company established in the EU, appointed in writing by a manufacturer based outside the EU, to act on its behalf for MDR obligations (Article 11). Great Britain has a similar role, the UK Responsible Person.

C

CE marking

The mark a manufacturer applies to show a device conforms to the EU MDR or IVDR. For most devices above Class I, CE marking needs a certificate from a notified body. Manufacturers then draw up a declaration of conformity.

Clinical evaluation(CER)

The ongoing process of collecting and assessing clinical data to verify a device is safe, performs as intended and has an acceptable benefit-risk profile (Article 61 and Annex XIV). The results are documented in the clinical evaluation report (CER), which forms part of the technical file.

Conformity assessment

The procedure that shows a device meets the regulation's requirements. The route depends on the device class and is set out in Annexes IX to XI of the MDR. Most routes involve a notified body.

D

Declaration of conformity(DoC)

A legal statement in which the manufacturer declares the device meets the MDR (Article 19 and Annex IV). It names the device, its Basic UDI-DI, its class and the conformity assessment route used.

Device classification

Medical devices under the EU MDR fall into Class I, IIa, IIb or III according to the rules in Annex VIII, based on intended purpose, duration of use, invasiveness and other factors. The class decides the conformity assessment route and much of the documentation needed.

E

EUDAMED

The European database on medical devices. It holds modules for actor registration, UDI and device registration, notified bodies and certificates, clinical investigations, vigilance and market surveillance. Use of its modules is becoming mandatory in stages.

G

General safety and performance requirements(GSPR)

The requirements in Annex I of the EU MDR that every device must meet. Manufacturers usually show compliance with a GSPR checklist that lists each requirement, whether it applies, the standards or methods used and where the evidence sits in the technical file.

I

In vitro diagnostic regulation(IVDR)

Regulation (EU) 2017/746, which governs in vitro diagnostic medical devices in the EU and replaced the earlier IVD Directive. It follows a similar structure to the MDR, with its own classification rules and technical documentation annexes.

Instructions for use(IFU)

The information the manufacturer supplies so a device can be used safely and as intended. Its required content is set out in Annex I, Chapter III of the EU MDR, and it forms part of the labelling reviewed in the technical file.

Intended purpose

The use for which a device is intended, according to the manufacturer's labelling, instructions, promotional material and clinical evaluation (Article 2(12)). Nearly everything in the technical file, from classification to clinical evidence, follows from it.

ISO 13485

The international standard for quality management systems for medical devices. The EU MDR requires manufacturers to have a quality management system (Article 10), and ISO 13485 certification is the usual way to demonstrate it.

ISO 14971

The international standard for applying risk management to medical devices. Manufacturers use it to identify hazards, estimate and control risks and judge whether residual risk is acceptable. The risk management file is a core part of the technical file.

L

Legacy device

A device still placed on the EU market under a certificate issued under the old Medical Device Directives. Under Regulation (EU) 2023/607, legacy devices can stay on the market until 31 December 2027 or 31 December 2028, depending on risk class, provided the manufacturer meets the conditions, including applying for MDR certification. MDD to MDR migration

M

Medical Device Directive(MDD)

Directive 93/42/EEC, the EU law that governed most medical devices before the MDR. Devices certified under it must transition to the MDR within the deadlines for legacy devices.

Medical Device Regulation(EU MDR)

Regulation (EU) 2017/745, which governs medical devices in the EU and has applied since 26 May 2021. It replaced the MDD and the Active Implantable Medical Device Directive and raised the requirements for clinical evidence, post-market surveillance and technical documentation. EU MDR technical file software

MHRA

The Medicines and Healthcare products Regulatory Agency, the UK regulator for medical devices. It oversees the UK MDR 2002, designates UK Approved Bodies and runs device registration in Great Britain.

N

Notified body

An independent organisation designated by an EU member state to carry out conformity assessment under the MDR or IVDR. Notified bodies review technical documentation, audit quality systems and issue CE certificates. They are listed in the European Commission's NANDO database.

P

Periodic safety update report(PSUR)

A report summarising post-market surveillance data and conclusions for Class IIa, IIb and III devices (Article 86). It is updated at least every two years for Class IIa and at least annually for Class IIb and III. Class I devices need a PMS report instead.

Person responsible for regulatory compliance(PRRC)

The named person a manufacturer must have to oversee regulatory compliance (Article 15). The role needs specific qualifications or experience. Micro and small enterprises do not need a PRRC in-house but must have one permanently and continuously available.

Post-market clinical follow-up(PMCF)

The continuous process of collecting clinical data on a CE-marked device in use, to confirm its safety and performance over its lifetime (Annex XIV, Part B). Findings feed back into the clinical evaluation.

Post-market surveillance(PMS)

The system a manufacturer uses to collect and review experience with its devices once they are on the market (Articles 83 to 86). It is described in the PMS plan, part of the Annex III documentation, and reported in a PMS report or PSUR.

S

Summary of safety and clinical performance(SSCP)

A public summary required for implantable and Class III devices (Article 32). It is validated by the notified body and published in EUDAMED.

T

Technical file

The common name for a device's technical documentation: the full body of evidence that shows the device meets the regulation. Under the EU MDR its content is set out in Annexes II and III. How Obodux helps you build it

U

UK Approved Body

A conformity assessment body designated by the MHRA to assess devices for UKCA marking in Great Britain, the UK equivalent of an EU notified body.

UK MDR 2002

The Medical Devices Regulations 2002, the law that governs medical devices in Great Britain. It is based on the earlier EU directives and is being updated by the MHRA.

UKCA marking

The UK Conformity Assessed mark for devices placed on the market in Great Britain under the UK MDR 2002. CE-marked devices remain accepted in Great Britain for a transition period, so check current MHRA guidance for your device. UKCA technical file

Unique device identification(UDI)

The system of identifiers that lets a device be traced through the supply chain (Article 27). The UDI-DI identifies the device model and the UDI-PI identifies the production unit, such as a lot or serial number. The Basic UDI-DI is the main identifier of a device model in EUDAMED and appears on certificates and the declaration of conformity.

V

Vigilance

The system for reporting and analysing serious incidents and field safety corrective actions involving devices on the market (Articles 87 to 92). Manufacturers must report serious incidents to the competent authorities within set deadlines.