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.
MDR
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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...
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...
Healthcare Insights: Medical Device Regulation Updates – What You Need to Know
Keeping up with the evolving medical device regulation and compliance landscape can be challenging, particularly when technical specifications from the EU Commission are repeatedly delayed. As a global software solution vendor for Life Sciences...
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...
No-Deal Brexit – Implications to Medical Device Regulations (MDR)
A no-deal Brexit (a disaster to some or the chance trade on our own terms to others) means the UK would leave the European Union (EU) immediately on 29 March 2019, and there would be no agreements in place about what their relationship would be...
Leveraging Your Wealth of Healthcare Data for Better Patient Care
Innovit at GS1 UK Healthcare Conference, London Managing the wealth of available healthcare data allows health systems to create holistic views of patients, personalize treatments, improve communication and enhance health outcomes....
Innovit, GS1 Global Healthcare Conference and new EUDAMED & MDR Challenges
We're attending the GS1 Global Healthcare Conference! Master data is at the center of important initiatives within healthcare including patient safety, post-market surveillance, supply chain optimization and regulatory compliance. While...