EU MDR ja IVDR
Labquality provides medical device manufacturers help with understanding the changing regulations
that set the standards of quality and safety of medical devices.
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Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (EU IVDR) will come into force on 26 May 2022, replacing Medical Device Directive 98/79/EC. However, the transition period of IVDR was extended at the end of 2021 beyond 2022 depending on the risk classification of the device (not for non-sterile class A devices). Still, the date of application remains, in other words, many of the IVDR requirements will apply on 26 May 2022. |
What are MDR and IVDR?
MDR and IVDR set standards of quality and safety for medical devices to protect the health of patients and users. They set new and stricter requirements for medical devices, their manufacturers, and the Notified Bodies. EU MDR and IVDR cover all devices, reagents and software used for medical purposes.
In addition to commercial manufacturers, certain requirements of the regulations apply also to health institutions’ in-house manufacturing of medical devices.
New obligations to importers, distributors and authorized representatives were introduced, as well.
The conformity assessment procedure of the devices belonging in the risk classes higher than class I (MDR) and class A (IVDR) requires the involvement of a Notified Body.
Due to the new classification rules for the devices, the number of devices requiring assessment by a Notified Body increases significantly, especially for IVD medical devices.
What requirements do MDR and IVDR bring?
Notified Bodies need to go through an approval process to be qualified for performing conformity assessments under the new regulations.
Now, there is a shortage of approved Notified Bodies for IVDR. Therefore, the European Commission has composed a proposal for an extension of the IVDR go-live dates
for those devices that require an assessment by a Notified Body, length of extension depending on the risk class of the device.
Labquality’s team has wide experience with both MDR and IVDR, covering it all: equipment, reagents as well as software.
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