We published our first essential guide to MDR in 2020. Since then, the new MDR regulation has been introduced. This updated essential guide for 2021 provides a fresh outlook on the challenges surrounding MDR.
Acorn Regulatory has been at the forefront of the MDR issue. The Essential Guide to MDR looks at the issue from a range of perspectives. Our expert MDR team has also written several whitepapers on the issue and they can be accessed here.
The application of the new MDR regulation on 26th May 2021 has brought about increased responsibility and changes in the medical devices sector. The pressure among stakeholders whether they be economic operators, notified bodies or competent authorities to adjust to these changes has been intense.
We hope that you find this revised essential guide to be useful.
What is a Medical Device under MDR?
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.
Understanding the changes in MDR in 2021
The advent of the new Medical Devices Regulation (MDR 2017/745) caused much concern for manufacturers and others in the devices sector. The new regulation has brought about many changes compared to the previous regulatory framework. We look at the basics of the new MDR and the changes that have impacted the device sector since May 26th, 2021. Read the full article here.
How Unique Device Identifiers Work
The Unique Device Identifiers system under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 IVDR incorporates new requirements for all participants of the supply chain, the objective of which is to improve patient safety through better traceability and transparency. Both MDR and IVDR have similar requirements with the only difference being timeline implementation. This article will focus on such requirements under the MDR. Read the full article here.
Post Market Surveillance under MDR
Regulation (EU) 2017/745 on medical devices (MDR) provides greater emphasis on Post Market Surveillance (PMS) and Post-market clinical follow-up (PMCF) requirements. This article examines the framework of requirements for manufacturers. Read the full article here.
PRRC: Person Responsible for Regulatory Compliance
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.
Conformity Assessment Routes under MDR
As part of our ongoing review of the changes that have been introduced by MDR, we examine Conformity Assessment routes in this article inclusive of changes under MDR and the assessment routes for different device classifications. Read the full article here.
EUDAMED Registration
With the introduction of the new MDR, we have noticed many new processes and systems being introduced. One of these has been the registration of all Medical Device Manufacturers in a totally new system called EUDAMED. We have prepared a short guide to help you navigate the complexities of EUDAMED. Read the full article here.
How we can help
Talk to us today about your MDR concerns. Email us at info@acornregulatory.com, or call us on 00353 52 61 76 706.
