MDR

Get the latest Innovit content today to help you with your business transformation.

An Important Milestone for the Medical Device Community: EU’s MDR-day has Arrived!

After four years of transition followed by a global pandemic in 2020, we reached a regulatory milestone on May 26, 2021 for Medical Device manufacturers in the European Union – with Medical Device Regulation 2017/745 finally taking effect. Yesterday, being the date of application of EU Medical Device Regulation (MDR) marks an important event for the medical devices market.

EU-MDR Date of Application – Postponed…

The European Parliament has formally voted and adopted the amendment of its Medical Device Regulation (MDR) date of application. The Parliament has tabled and supported the four technical amendments proposed last week by the European Council,...

URGENT: MDR Implementation – Postponed by EU Commission

The European Commission has announced a proposal to delay enforcement of the EU Medical Device Regulation by one year, from 26 May 2020 to 26 May 2021.  The intent is to help relieve pressure from national competent authorities, notified bodies,...

MDR and Class I Medical Devices – What’s In, What’s Out?

European Commission announced last October that the new EUDAMED will not launch until May 2022, giving everyone enough time to properly prepare for implementing M2M data exchange with EUDAMED.  Further, a grace period was also introduced by the EU...

EUDAMED & MDR: Readiness Tips

EUDAMED & MDR: Readiness Tips

With a May 2021 go live date, The European Database for Medical Devices (EUDAMED) will be open to many more groups, including manufacturers, importers and sponsors.  Current estimates are that this covers 70,000+ individual organizations and over...