MDR Delay: Regulations Delayed Until May 2021
The MDR delay has been anticipated for some time, as a result of the Covid-19 pandemic. The European Parliament has now voted to formalise the delay and to suspend introduction of MDR until May 2021.
Definition of a Medical Device: Explainer
MDR 2017/245 covers devices that previously fell under two separate European directives, the Medical Devices Directive (MDD 93/42/EEC) and the Active Implantable Medical Devices Directive (AIMDD 90/385/EEC). In this article, we look at the definition of a medical device and...
Post Market Surveillance under Medical Device Directive (2017/745)
Regulation (EU) 2017/745 on medical devices (MDR) now has increased requirements on specific Post Market Surveillance (PMS) and Post-market clinical follow-up (PMCF) requirements. In this article, we look at the requirements for manufacturers.
How Unique Device Identifiers Will Work Under MDR
The Unique Device Identifiers system under the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 IVDR applies new requirements on all participants of the supply chain with the final aim to improve patient safety through better traceability and transparency. Both...
Most Read Medical Device Articles of 2019
2019 has been a busy year for people involved in the medical devices sector. The imminent arrival of MDR, on May 26th next year, is concentrating the minds of those within the industry. It has been a busy year also...
Device Vigilance System Additional Guidance: An Update from Our Devices Team
While much of the medical device industry is focused on MDR, the MDD is still in effect. Our medical devices team has been following the latest developments on MDD and MDR on behalf of our client companies. In this article she...
2018’s Most Read Medical Device Articles from Acorn Regulatory
The Acorn Regulatory medical devices team has grown again in 2018 and in the past 12 months we have worked with a wide array of companies from around the world. In that time also, we have written a number of...
Brexit & Notified Bodies – What Are The Implications for the Medical Devices Sector?
The implications of Brexit will, possibly, be felt most in the area of Notified Bodies. The UK’s exit from the European Union means that UK based Notified Bodies will no longer be permitted to provide conformity assessment services and issue CE...
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How Ever-Changing Regulatory Demands Will Impact Small and Emerging Pharmaceutical and Medical Device Companies
Life science companies face considerable challenges aside from developing and launching new medicinal products and medical devices. The consistent pace of change means that companies must maintain understanding of developments in the sector. In this article, we look at some...
Most Read Medical Device News Stories on AcornRegulatory.com in 2016
We’re looking at the 5 most read medical device news stories from AcornRegulatory.com for the past 12 months. What a year we have had globally.
