Are your medical devices compliant with the European Union’s Medical Device Regulation of 2017? If not, no worries, we have got your back.
After getting the transition period postponed for a year — mainly due to the COVID-19 outbreak, Brexit, and lack of Notified Bodies — MDR will finally come into effect on 26 May 2021. With MDR 2017/745 replacing the existing rules governing medical devices in the EU, manufacturers will soon have to reassess their products for compliance.
On behalf of our clients, Galena Pharma can work as a legal manufacturer (CE holder) in handling the obligation of the manufacturer required by the law. Our experts can advise, inform and ultimately carry out any necessary technical documentation review and auditing required for your medical devices to remain compliant for the EU markets.
The Medical Device Team at Galena is equipped and ready to act even on short notice.
Contact our regulatory affairs expert Heidi Taipale at heidi.taipale@galena.fi and plan a meeting today.
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