Medical Devices

Clinical Investigation MDR

Carrying Out A Clinical Investigation Under MDR

As part of our ongoing series in advance of the MDR deadline, we are looking at clinical investigations and how… 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

Post Market Surveillance part of the Acorn Regulatory series on MDR

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… Read more

MDR Whitepaper 3 from Acorn Regulatory

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… Read more

MDR 2017/745 Importers & Distributors Acorn Regulatory

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… 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 apply 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?  In this… 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

2nd MDR whitepaper from Acorn Regulatory

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… Read more

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