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.
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.
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.
These products are subject to the IVDR (EU) 2017/746 (In-Vitro Diagnostic Regulation).
Software is considered a medical device if it is intended for a medical purpose, such as diagnostic support, image analysis, or therapy planning.
Not all software in the healthcare sector is automatically a medical device. The decisive factor is the Medical Purpose.
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.
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.
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:
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.
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.
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.
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:
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.
Affixing the CE marking to the product (and packaging) indicates proven conformity with the general Safety and Performance Requirements. For many medical devices, the identification number of the notified body must also be indicated next to the CE marking.
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
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:
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:
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.
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.
The General Safety and Performance Requirements (ESPR) are the central requirements for the safety and performance of medical devices according to the MDR. Manufacturers must demonstrate compliance with these requirements in the technical Documentation.
They are defined in Annex I of the MDR and concern, among other things:
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.
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.
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