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.
Download the 3rd Acorn Regulatory MDR Whitepaper
The 3rd Acorn Regulatory MDR whitepaper is available now. This publication looks at Clinical Evaluation Reports, Conformity Assessment Routes and Clinical Investigations under MDR.
Six Responsibilities of Importers and Distributors under MDR 2017/745
MDR 2017/745, which comes into force on May 26th, 2020, greatly expands the responsibilities of importers and distributors in comparison to the current MDD 93/42/EEC. In this article, we look at the responsibilities of the importer and the distributor.
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...
Exclusive MDR Content
Our expert team has written an extensive overview of the changes that MDR will bring for medical device companies. This exclusive MDR content looks at the changes that device manufacturers, importers, and distributors can expect to have to deal with...
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...
2nd Acorn Regulatory MDR Whitepaper: Be Prepared for May 2021
Our second Acorn Regulatory MDR whitepaper looks at the issues of unique device identifiers, the role of Eudamed under MDR and post market surveillance.
2nd MDR Whitepaper: Get An Advance Copy
We will be publishing our 2nd MDR whitepaper ‘Be Prepared’ in October. You can sign up to receive a copy before it is available on general release. The second whitepaper will look at 5 areas that will impact device manufacturers...
DEKRA Chosen As 3rd Notified Body Under MDR
DEKRA, the German-based company, has been chosen by The European Commission as the third notified body to be accredited under the Medical Device Regulations (MDR). The new regulations come into effect on May 26th 2020.
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...
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