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Daily Archives: June 4, 2021

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Latest Designated Notified Bodies under MDR and IVDR

Regulatory NewsBy AdminJune 4, 2021

Eurofins Expert Services Oy of Finland is the latest European Notified Body designated under the Medical Devices Regulation (EU) 2017/745 (MDR), before the Date of Application (DOA) on May 26, 2021. It has been listed in the NANDO database and assigned a Notified Body number of 0537. This brings the total number of Notified Bodies…

New guidance documents published by the European Commission

Regulatory NewsBy AdminJune 4, 2021

The date of application of Regulation (EU) 2017/745 on medical devices is approaching and the European Commis­sion has issued new and updated guidance documents. Please find below a list of the corresponding papers and let us know should you require a copy: – Factsheet for Class I Medical Devices – What You Need to Know…

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