MDR

MDR Delay

MDR Update – Will MDR Be Delayed?

The Covid-19 crisis has impacted every facet of modern life.  The life sciences sector has been at the centre of… Read more

Essential Guide To MDR from Acorn Regulatory

Acorn Regulatory’s Essential Guide to MDR

Acorn Regulatory has been at the forefront of the MDR issue.  While many economic operators across the industry have been… Read more

Definition of a medical device

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… Read more

Regulatory Intelligence 8

Download ‘Regulatory Intelligence 8’

Edition 8 of the Acorn Regulatory whitepaper series ‘Regulatory Intelligence’ is out now and can be downloaded from our site. … Read more

Clinical Evaluation Report Requirements Under MDR

Regulation (EU) 2017/745 has expanded the requirements related to Clinical Evaluation and Clinical Investigations with Chapter VI (Articles 61 to 82) covering this… Read more

The Risk Based Classification System Under IVDR 2017/746

One of the key changes in the new IVDR Regulation 2017/746, is the introduction of a risk-based classification system for… Read more

Understanding MDR The Role of the PRRC Responsible Person

The 5 Responsibilities of the Person Responsible for Regulatory Compliance (PRRC) under MDR

This article is part of our series of MDR articles that look at the changes coming into play with the… Read more

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

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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