2017/745 - EN - Medical Device Regulation - EUR-Lex
May 5, 2017 · Any device which, when placed on the market or put into service, incorporates as an integral part an in vitro diagnostic medical device as defined in point 2 of Article 2 of Regulation (EU) …
ANNEX VIII - Medical Device Regulation
Aug 8, 2019 · ‘Active device intended for diagnosis and monitoring’ means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, …
Annex VIII (MDR): Classification rules
‘Active therapeutic device’ means any active device used, whether alone or in combination with other devices, to support, modify, replace or restore biological functions or structures with a view to …
Definition of duration of use for medical devices explained
According to the intended use, the medical device has an assigned duration of use. This duration can be classified into 3 groups, i.e. the transient, the short term and the long term use.
Classification rules | 13485Academy - Advisera
‘Active therapeutic device’ means any active device used, whether alone or in combination with other devices, to support, modify, replace or restore biological functions or structures with a view to …
Short term [MDR] | NEMIUS Medical Europe GmbH & Co. KG
‘Short term’ means normally intended for continuous use for between 60 minutes and 30 days. [Definition according to (EU) 2017/745 Annex VIII Chapter I No. 1.2]
What you need to know about the MDR classification rules
Sep 4, 2020 · The Medical Device Regulation (MDR) EU 2017/745 defines in its Annex VIII the classification rules for medical devices. Read here how these rules are broken down and find …
Download MDR - Medical Device Regulation
Download from the link below the MDR in the main European languages. If you prefer the HTML with TOC version just look into the HMTL column ans select the version for your native language.
Medical Device Classification under EU MDR [Overview]
May 1, 2024 · One of the most important steps in bringing a medical device to market in the European Union (EU) is determining the correct classification for your device. The EU medical device …
May 6, 2017 · As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation harmonises the rules for the placing on the market and putting into service of medical …