Most Read MDR Articles of 2020

Acorn Regulatory has been at the forefront of the MDR issue.  While many economic operators across the industry have been busy preparing for implementation in May 2020, there is some uncertainty at present (March 2020) whether this date will be delayed because of the necessity of the life sciences sector to combat the Covid-19 crisis in Europe.

The ‘Essential Guide’ looks at MDR from a range of perspectives.  Our expert MDR team has also written several whitepapers on the issue and they can be accessed here.

The date of application of MDR of 26th May 2020 has long been recognised as a very ambitious target by many in the medical devices sector. The pressure among stakeholders whether they be economic operators, notified bodies or competent authorities to be ready in time has been intense. The delay of Eudamed and the well-documented issues around capacity in the Notified Body network are just two examples of areas of difficulty in being ready for MDR implementation.

The outbreak of Covid-19 has added unprecedented extra pressures on the medical device sector. The European Commission is working on a proposal to postpone the application date of MDR by one year. It will be submitted to European Parliament and Council in early April for adoption before the end of May.

We will keep you updated about MDR issues as the proposal to delay implementation progresses.

We hope that you find this essential guide to be useful.

1) 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 Active Implantable Medical Devices Directive (AIMDD 90/385/EEC).  In this article, we look at the definition of a medical device and explain the types of products that might be classified as a device after May 2020.  This article is part of our wider series looking at issues relating to the introduction of MDR. Read the full article here.

2) Understanding MDR: 8 Important Changes

The advent of the new Medical Devices Regulation (MDR 2017/745) is a cause of much concern for manufacturers and others in the devices sector.  The new regulations will bring about many changes compared to the current regulatory framework.  We look at the basics of the new MDR and the changes that will impact the device sector from May 26th, 2020. Read the full article here.

3) 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 new medical device regulations.  In this article, we are looking at the role of the Person Responsible for Regulatory Compliance (PRRC).

The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European medical devices legislation that a person is required to be appointed by a manufacturer to take specific responsibility for regulatory compliance of devices.  Read the full article here.

4) 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 they will operate after the MDR has been introduced in May 2020. We have written extensively on the MDR issues and at the end of this article, you can access our range of whitepapers and other articles that look at the changes that the new regulations will bring about.  Read the full article here.

5) 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 in this article.  We look at changes under MDR and the assessment routes for different device classifications. Read the full article here.

6) 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.  Read the full article here.

7) 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 MDR and IVDR have similar requirements with only the implementation of timelines being different.  In this article, we will focus on the needs under MDR.  Read the full article here.

8) 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. Read the full article here.

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