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11 Posts in this encyclopedia categoryManufacturer
Manufacturer is the natural or legal person who develops, manufactures, or as the responsible person markets a medical device under their own name. Under MDR (EU) 2017/745, the manufacturer bears responsibility for product conformity and is required to maintain a quality management system.
Medical Device
A medical device is defined under MDR (EU) 2017/745 as any instrument, apparatus, software, implant, or material intended for medical purposes whose principal intended action is not achieved by pharmacological, immunological, or metabolic means. Classification into four risk classes (I, IIa, IIb, III).
Medical device class II a
Class IIa medical devices represent moderate risk under MDR (EU) 2017/745. Typical examples: hearing aids, surgical needles, injection syringes. A Notified Body must be involved in the conformity assessment. Class IIa sits between Class I (low risk) and Class IIb (higher risk).
Medical device class II b
Class IIb medical devices have a higher risk potential under MDR (EU) 2017/745 and sit one level below the highest risk Class III. Typical examples: ventilators, defibrillators, surgical lighting systems. Notified Body and strict conformity assessment requirements apply.
Medical device class III
Class III medical devices are the highest risk category under MDR (EU) 2017/745. They include implants, products in direct cardiac contact, and resorbable products. Strictest conformity assessment requirements, Notified Body mandatory, and clinical investigations generally required.
Medical devices class I
Class I medical devices represent the lowest risk class under MDR (EU) 2017/745. They include non-invasive products with minimal risk potential. The manufacturer may carry out the conformity assessment independently without involving a Notified Body. Example: medical single-use gloves per EN 455.
Medical devices class I m
Class Im medical devices are Class I products with a measuring function whose measurement results are significant for diagnosis or therapy. A Notified Body is required for the measuring function. The remainder of the product stays Class I.
Medical devices class I r
Class Ir medical devices are Class I products intended for reuse as surgical instruments and requiring cleaning, disinfection, or sterilisation before reuse. A Notified Body must be involved for the reprocessing aspect.
Medical devices class I s
Class Is medical devices are Class I products supplied in a sterile condition. Despite the Class I classification, a Notified Body is required for the sterilisation aspect. The sterilised product itself remains Class I; only the sterilisation process requires third-party assessment.
Medical Devices Regulation / MDR (EU) 2017/745
MDR (Medical Device Regulation) (EU) 2017/745 is the European regulation for medical devices. It replaced Directive 93/42/EEC (MDD) in May 2021 and governs classification, approval, labelling, clinical evaluation, and market surveillance of all medical devices on the EU market. Medical devices may not be sold in the EU without MDR conformity.
Medizinischer Handschuh
Medical glove is the umbrella term for single-use gloves classified as medical devices under MDR (EU) 2017/745 and complying with the EN 455 standard series. This includes examination gloves (NON STERILE, AQL 1.5), surgical gloves (STERILE, AQL 0.65), and chemotherapy gloves.