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How Will The Northern Ireland Protocol Impact Medical Device Companies?

Our clients have been contacting us in recent weeks with questions relating to the Northern Ireland Protocol and medical devices. … Read more

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What Is A Unique Device Identifier?

The Unique Device Identifier system under the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 IVDR applies new requirements on… Read more

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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… Read more

Clinical Evaluation Reports

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… Read more

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… Read more

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. … Read more

Unique Device Identifiers MDR Acorn Regulatory

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… Read more

Steps to CE Marking an IVD Medical Device

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… Read more

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… Read more

Contact us and enjoy a faster, smoother journey through the maze of European Pharmaceutical and Medical Device legislation with us as your expert guide.
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