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1 Μαΐ 2019 · With the implementation of the EU Medical Device Regulation (EU 2017/745) and In Vitro Diagnostic Regulation (EU 2017/746), some companies that contract manufacture devices are wondering if they will be considered the “legal manufacturer” of the device they sell.
- Preparing For The EU MDR 2020 Changes
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- MDR Table of Contents
If you have downloaded the 175-page European Medical Device...
- Preparing For The EU MDR 2020 Changes
10 Ιουλ 2019 · (1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
‘Medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human...
Medical devices are products or equipment intended for a medical purpose. In the European Union (EU) they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended.
The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the human body and the potential risks associated with the devices.
31 Μαΐ 2021 · As of May 26, 2021, medical device companies must now comply with the EU's Medical Device Regulation (MDR) requirements, and the In Vitro Diagnostics Regulation (IVDR) requirements are effective in May 2022. This article examines the role of the contract manufacturer under these regulations.
What is a legal manufacturer MDR? Under the European Union's Medical Device Regulation (EU MDR), the term "legal manufacturer" refers to the entity legally responsible for the medical device in terms of compliance with the regulation.
