DE: Beratung Zulassung und Zertifizierung von Medizinprodukten EN: Consulting and Certification Medical Device

Medical Device Glossary

Explanation of the Key Terms

Medical devices are subject to clearly defined regulatory requirements in Europe.
This medical devices glossary explains the key terms from MDR, IVDR, CE marking, conformity assessment, and post-market surveillance in a clear and practical way.

The glossary is intended for manufacturers, developers, and medical technology companies that want to launch medical devices on the EU market.

Medical devices are subject to clearly defined regulatory requirements in Europe. This medical devices glossary explains the key terms from MDR, IVDR, CE marking, conformity assessment, and post-market surveillance in a clear and practical way.

Contents

Medical Devices in the EU

A Medical Device is an instrument, apparatus, appliance, software, implant, reagent, material, or other article that, according to the manufacturer, is intended for human beings and is intended to fulfill one or more of the following specific Medical Purposes, either alone or in combination.

These include, among other things, the diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of diseases, injuries, or disabilities; the investigation, replacement, or modification of the anatomy or of a physiological or pathological condition; or the obtaining of information through the in vitro examination of specimens derived from the human body. The main intended effect in or on the human body is not achieved by pharmacological or immunological means, nor by metabolic means, but its mode of action may be supported by such means.

The Intended Purpose describes the use of a medical device as intended by the manufacturer. It is specified in the labeling, instructions for use, technical documentation, and advertising materials.

It is of central importance for Classification according to MDR, Clinical Evaluation, Conformity Assessment, and Risk Management.

> Art. 2(1) MDR (EU) 2017/745

In-Vitro Diagnostic Devices  are Medical Devices used to examine samples from the human body, such as blood, tissue, or urine. They are used to obtain diagnostic information about a patient’s state of health.

They fall not under the MDR but under the IVDR (EU) 2017/746, with their own classification and conformity rules.

> Art. 2(2) IVDR (EU) 2017/746

Software is considered a medical device if it is intended for a medical purpose, such as diagnostic support, image analysis, or therapy planning. Standalone software is classified under Rule 11 of Annex VIII MDR. Correct function is demonstrated through software validation.

Not all software in healthcare is covered; what matters is the medical intended purpose, not the platform.

> Annex VIII, Rule 11 MDR

A custom-made medical device is a medical device that is specifically manufactured according to specific design characteristics based on a written prescription and is intended for exclusive use by a named patient.

A mass-produced medical device that needs to be adapted to meet the specific requirements of a physician, dentist, or other professional user is not considered a custom-made medical device.

> Art. 2(3) MDR

Yes, accessories for medical devices are objects, substances, and preparations made from substances, as well as software, which are not medical devices themselves but are intended by the manufacturer to be used with a medical device so that it can be used in accordance with its intended purpose.

> Art. 2(2) MDR

Placing on the market means any supply, whether free of charge or not, of medical devices to others.

The following are not considered to be placing on the market under this law:

> Art. 2(28) MDR

  •  

Regulatory Framework: MDR, IVDR, EUDAMED

The Medical Device Regulation (MDR, Regulation (EU) 2017/745) is the central European regulation for medical devices. It regulates market access, safety requirements, clinical evaluations, and market surveillance. All medical devices in Europe are subject to the MDR.

The MDR has been binding in the European Union since May 2021.

> Regulation (EU) 2017/745

The Medical Device Regulation (MDR, Regulation (EU) 2017/745) is the central European regulation for medical devices. It regulates market access, safety requirements, clinical evaluations, and market surveillance. All medical devices in Europe are subject to the MDR.

The MDR has been binding in the European Union since May 2021.

> Regulation (EU) 2017/745

The In Vitro Diagnostic Regulation (IVDR, Regulation (EU) 2017/746) is the regulatory framework for in vitro diagnostic medical devices in the EU. Among other things, it defines the classification rules, conformity assessment procedures, performance evaluation, and post-market surveillance.

> Regulation (EU) 2017/746

EUDAMED is the European database for medical devices and is part of the MDR regulatory framework. It is used to register manufacturers, products, certificates, and vigilance reports, thereby supporting transparency and market surveillance within the framework of the MDR.

> Art. 33 MDR

The UDI (Unique Device Identification) is a globally unique product code. It has two parts: the UDI-DI, which identifies the device model, and the UDI-PI, which captures production data such as lot, serial number, or expiry date.

The manufacturer assigns the UDI through a designated issuing entity, places it on the label and packaging, and registers the UDI-DI in EUDAMED. The UDI runs through the entire technical documentation as a chain of evidence from traceability to vigilance.

> Art. 27 MDR · Annex VI Part C

ISO 13485 is an internationally recognized standard for Quality Management Systems of medical device manufacturers. Certification according to this standard is often checked by a notified body as part of the MDR conformity assessment.

The standard defines requirements for:

  • Development and manufacture of medical devices
  • Risk management
  • Technical documentation
  • Regulatory processes
  • Market surveillance

Conformity Assessment and CE Marking

A conformity assessment procedure is a structured process that manufacturers can use to demonstrate that a medical device meets the requirements of the MDR or IVDR.

The procedure forms the basis for the CE marking.

The CE marking confirms that a medical device complies with European regulatory requirements and may be placed on the market in the European Economic Area. It is not a “CE certification”, it is the visible result of a completed conformity assessment.

The basis is fulfillment of the General Safety and Performance Requirements in Annex I. From Class IIa upward, a notified body reviews the device before the mark may be affixed.

> CE marking and conformity assessment under MDR

The General Safety and Performance Requirements (GSPR) are set out in Annex I MDR. They define the properties a device must have in terms of safety, performance, and benefit-risk ratio, independent of the conformity assessment route chosen.

For each device, the manufacturer demonstrates in a GSPR checklist which requirement applies, which harmonized standard is used to meet it, and where the evidence sits in the technical Documentation:

  • Risk management
  • Biological safety
  • Electrical safety
  • Suitability for use
  • Clinical evaluation
  • Labeling and instructions for use

> Annex I MDR
> General Safety and Performance Requirements in detail

A conformity assessment is the structured demonstration that a device meets the MDR. Which route the manufacturer takes depends on the risk class.

Annex IX combines assessment of the quality management system with review of the technical documentation and is the broadest route, available up to Class III. Annex X (type-examination) examines a representative device type, combined with Annex XI (production conformity), which ensures that series production matches the examined type. Class I devices without a special case self-declare their conformity; where a device is sterile, has a measuring function, or is a reusable surgical instrument, the notified body reviews that specific aspect.

> Annex IX / X / XI · Art. 52 MDR

The Declaration of Conformity is the document by which the manufacturer declares, under its own responsibility, that the device meets the MDR. It is not a certificate from the notified body, it is the legally binding manufacturer’s declaration and the precondition for CE marking.

The mandatory content is set out in Annex IV: identification of the device and manufacturer, the Basic UDI-DI, reference to the legislation applied, and (from Class IIa) reference to the certificates issued. The manufacturer keeps the DoC up to date and makes it available to the authorities.

> Art. 19 · Annex IV MDR

The EU has no governmental “approval” like a medicinal product, and no single “TÜV stamp” for a medical device. Market access runs through the conformity assessment, which the manufacturer owns. Whether a notified body is involved depends on the risk class.

Class I without a special case: manufacturer’s self-declaration. From Class IIa: review by a notified body. Testing organizations such as TÜV entities act here as notified bodies, as an accredited assessment body. The first step is always the classification.

Economic Operators and Responsibilities

The MDR defines four economic operators with clearly separated obligations. Which role an entity holds is decided not by contract but by activity.

OperatorCore obligationReference
ManufacturerCarries overall responsibility: conformity, technical documentation, declaration of conformity, post-market surveillance, vigilanceArt. 10
Authorised Representative (EC-REP)Represents a non-EU manufacturer before the authorities; checks formal obligations, holds documentation available.Art. 11
ImporterBrings devices from third countries onto the Union market; verifies CE, DoC, labeling, and registration before supply.Art. 13
DistributorMakes devices available in the supply chain; checks labeling and the presence of CE and DoC, reports issues.Art. 14

The authorised representative acts on behalf of a manufacturer without an EU seat. It is the manufacturer’s legal point of contact in the Union, receives communication from authorities, holds the technical documentation available, and can share liability for certain breaches. It is part of the manufacturer’s side.

The importer is an independent link in the supply chain. It brings the device physically onto the market and verifies, before supply, that CE marking, declaration of conformity, labeling, and registration are in place. The authorised representative checks the regulatory representation; the importer checks the specific consignment. The two roles cannot fall to the same entity.

> Art. 11 vs. Art. 13 MDR

The distributor makes devices available without being manufacturer or importer. Before supply, it verifies that CE marking and declaration of conformity are present, that labeling and instructions for use are provided, and that the importer’s details have been added.

If it identifies a non-conforming device, it may not make it available and informs the parties involved. Where it suspects a risk, it reports to the manufacturer, the authorised representative, and the competent authority. Storage and transport must follow the manufacturer’s conditions.

> Art. 14 MDR

The PRRC is the person responsible for regulatory compliance. Every manufacturer and every authorised representative must designate at least one such person and demonstrate their qualification, through a relevant degree plus professional experience, or through several years of relevant experience.

The PRRC ensures that conformity is checked, that technical documentation and the declaration of conformity are kept current, that post-market surveillance obligations are met, and that reporting duties are observed. In small and medium-sized enterprises, the function may be filled externally.

> Art. 15 MDR

No qualified PRRC in place means the manufacturer’s obligations are not fully met.

> Arrange an external PRRC.

A Notified Body is an independent organization responsible for conducting tests and issuing certificates in connection with conformity assessment procedures and designated by a signatory state to the Agreement on the European Economic Area.
Notified Bodies are required in particular for products in risk classes IIa, IIb, and III.

Both review — but at different levels. Confusing them regularly leads to false expectations about the process.

RoleFunction
Competent Authority A governmental authority. Supervises the market, handles vigilance reports, designates and oversees notified bodies, and orders measures up to market withdrawal. In Germany, e.g. the BfArM and the state authorities.
Notified BodyAn accredited, private assessment organization. In the conformity assessment, it evaluates the quality management system and the technical documentation and issues certificates. Not an authority, but designated by one.

An authorized representative is a natural or legal person established in the European Economic Area who has been expressly designated by the manufacturer to act on his behalf with regard to his obligations under this law and to be available to the authorities and competent bodies.

Quality Management, Risk Class and Clinical Evidence

Medical devices are divided into four risk classes according to the MDR. As the Risk Class increases, so do the regulatory requirements and the scope of testing by a Notified Body.

The classification is divided into the following classes: Class I, IIa, IIb, and III

EN ISO 14971 describes the process by which manufacturers identify, evaluate, control, and monitor the risks of a medical device across its life cycle. The result is the risk management file, which documents each step traceably.

Risk management is not a one-time document; it runs alongside post-market surveillance, with new field findings feeding back into the risk assessment.

> Risk Management System under EN ISO 14971

ISO 13485 is the internationally recognized standard for quality management systems of medical device manufacturers. It describes the requirements for a QMS across the entire product life cycle.

The MDR and ISO 13485 are not the same. The MDR requires a QMS (Art. 10(9)) but does not prescribe any particular standard. ISO 13485 is the established way to build that QMS; notified bodies expect it in practice. An ISO certificate alone, however, does not prove MDR conformity.

> Quality Management System ISO 13485

The MDR is law. ISO 13485 is a voluntary standard. The MDR sets out what a device must meet and demonstrate to be marketable in the EU. ISO 13485 describes how a company organizes its quality management so that it can meet such requirements reliably.

A QualityManagement System (QMS) encompasses all organizational processes, responsibilities, and procedures that a manufacturer uses to ensure that its medical devices meet regulatory requirements and maintain consistently high quality. A functioning QMS is the basis for the conformity assessment procedure.

A QMS is mandatory for medical device manufacturers under the MDR and includes, among other things:

  • Document control
  • Risk management
  • Post-market surveillance
  • CAPA processes
  • Supplier management

The technical Documentation contains all information that enables the safety, performance, and regulatory compliance of a medical device to be demonstrated. The exact requirements are defined in Annexes II and III of the MDR.

These include, among other things:

  • the product description,
  • the risk management file, the clinical evaluation,
  • the instructions for use and labeling
  • and the verification and validation evidence.

The Clinical Evaluation is a systematic and continuous process for collecting, analyzing, and evaluating clinical data to demonstrate the safety and clinical performance of a medical device.

The purpose is to demonstrate that the medical device achieves the intended clinical performance, is suitable for its intended purpose, has an acceptable benefit-risk profile, and corresponds to the generally recognized state of the art.

It rests on clinical data, from a manufacturer’s own clinical investigation, from literature, or from post-market surveillance.

The evaluation must address the specific device, not the device class.

> Clinical Evaluation under MEDDEV 2.7/1

For in-vitro diagnostic devices, the performance evaluation is the counterpart to the clinical evaluation of medical devices. It demonstrates that an IVD delivers the performance the manufacturer claims on three pillars: the scientific validity of the analyte, the analytical performance (the device measures correctly), and the clinical performance (the result means what it should).

The evidence is brought together in the performance evaluation report and kept current through post-market performance follow-up (PMPF). The requirement is regularly underestimated, it decides IVDR conformity.

> Art. 56 · Annex XIII IVDR

After Placing on the Market: Surveillance and Vigilance

Post-market surveillance begins when a device is placed on the market. The manufacturer systematically collects data on the safety and performance of its device in real use, evaluates it, and derives actions.

The findings feed back into risk management, clinical evaluation, and technical documentation. PMS is the loop that holds conformity over time.

> Art. 83–86 MDR

> Post-Market Surveillance (PMS & PMCF)

Post-Market Surveillance (PMS) describes the systematic monitoring of a medical device after it has been placed on the market. The aim is to monitor safety and performance in real-world use. PMS includes, among other things, collecting data from the market, evaluating complaints, analyzing trends, and updating the clinical evaluation.

Post-Market Clinical Follow-Up (PMCF) refers to the continuous collection of clinical data after a medical device has been placed on the market. It serves to confirm the clinical evaluation in the long term and may include clinical follow-up studies, registry data, user feedback, and literature analyses.

PMCF (Post-Market Clinical Follow-up) is the proactive part of surveillance: the targeted collection of clinical data after placing on the market, to keep the clinical evaluation current.

The PSUR (Periodic Safety Update Report) summarizes the surveillance results periodically, frequency and scope depend on the risk class.

> Art. 61 · Art. 86 · Annex XIV Part B MDR

The vigilance system governs the reporting of serious incidents to the competent authority. A reportable incident exists where a device has led, or could have led, to death, serious deterioration in health, or a serious threat. The reporting deadlines are short and tied to severity.

An FSCA (Field Safety Corrective Action) is a corrective action in the field to reduce a risk: a software update, a retrofit, or a recall. The recall is the strongest form of FSCA: withdrawal of the device from the market. The manufacturer informs affected users through a Field Safety Notice.

> Art. 87–92 MDR

Technical Terms and Informal Language

The following table matches common expressions with their regulatory terms. This is not to correct colloquial language, but to clarify which regulatory obligation actually lies behind each term.

Technical termInformal SynonymsShort definition
Conformity assessment“MDR approval”, “getting CE”, “CE mark,” “approval,” “registration”Process for verifying whether a product complies with the MDR
Notified body“TÜV”, “test lab”, “certification body”Accredited organization that conducts testing and certification as part of the process
Technical documentation“Product File”, “Paperwork”, “Documentation,” “Technical File,” “Technical Record,” “Medical Device File,” “TD” Comprehensive evidence of a product’s conformity (Annex II/III MDR)
Intended purpose“Purpose”, “Intended Use”Use foreseen by the manufacturer
Placing on the market “selling,” “registering,” “authorizing” The first time a product is made available on the market, whether for a fee or free of charge
FSCA“Recall,” “Safety Action”Corrective action taken in the market to reduce risk
PRRC“Authorized Representative,” “Representative”Person responsible for compliance with regulatory requirements
Declaration of Conformity“CE document,” “CE mark,” “DoC”Confirms that a medical device meets the requirements of the Medical Devices Regulation (MDR) (EU) 2017/745
Manufacturer“contract manufacturer,” “producer”Legally binding manufacturer’s declaration of MDR conformity

What consulting specialties are available?

A medical device goes through several regulatory processes, from evaluation to registration. WQS supports these regulatory processes for medical devices and in vitro diagnostic medical devices with consulting services in the following areas:

Clinical Evaluation & PMS

Biological Evaluation

Usability

Active Medical Devices

Packaging, Testing & Laboratory

In-Vitro Diagnostics

Risk Management

Labeling, UDI, and Registration

Medical Devices • Glossary • FAQ

WQS provides detailed information on your topic.

We are always available to answer any further questions or provide a personalized consultation.

Schedule your first free initial consultation

Support for US companies to enter the European market. EU Rep, Certification, QM System, Technical Documentation, support of the Procedure, selection of a Notified Body, support of the Certification Procedure, preparation of a Clinical Evaluation, support of Clinical Studies, including the Logistical Concepts.

HOTLINKS

Contact

WQS Management Consultants Inc
136 4th Street north, Suite 201
St Petersburg, Florida 33701

Telefon: (925) 212-7683
Email: werner@us.wqs.de
Web: us.wqs.de

Instagram Linkedin

Did you know?

Copyright 2026 WQS Management Consultants GmbH – Alle Rechte vorbehalten

This page provides regulatory information and does not constitute legal advice. Regulatory requirements vary by jurisdiction.
Image note: Certain images and photos used on this page were created or edited, in whole or in part, with artificial intelligence.