Moving from MDD to MDR? Here Is What You Need To Know
MDR will come in to force in 2021. It differs greatly from the MDD. What will the major changes be for medical devices manufacturers, importers, and distributors? We look at the major changes in the move from MDD to MDR...
How To Write An Effective CER
The clock is ticking for medical device manufacturers distributing in the European Union (EU). The EU is transitioning from the Medical Device Directive (MDD) to the new Medical Device Regulation (MDR). The updated European Medical Device Regulation (MDR) introduced in...
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.
Conformity Assessment Routes Under MDR 2017/745
As part of our ongoing look at the changes being brought about by MDR, we look at Conformity Assessment routes. We look at changes under MDR and the assessment routes for different device classifications.
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...
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Steps to CE Marking an IVD Medical Device
One of the most frequent questions we are asked is: how do you CE mark an IVD device? We will look at the steps that you need to take to obtain when CE marking an IVD device. As the new...
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...
Impacted By The LRQA Decision? Here Is How We Can Help
The decisions by Lloyd’s Register Quality Assurance (the LRQA) and QS Zurich that they will both will cease to offer notified body services under the EU’s existing medical device and in vitro diagnostic directives and that they will not seek...
Get The Acorn Regulatory Medical Device Regulations Whitepaper
The new medical device regulations (MDR) will come into force in May 2020. In advance of the deadline, companies across the world are working to ensure that their devices will comply with the new regulations. For many companies there is...
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