Download our Clinical Evaluation Report Slide Deck
The most significant change from the MDD to the MDR is the increased focus on clinical evaluation, access to data, and post-market surveillance. This places a greater burden upon manufacturers and their representatives, and it is something that we, at Acorn Regulatory, have been helping our clients with. We have created a brief Clinical Evaluation Report Slide Deck that looks at how you can write an effective clinical evaluation report. This slide deck will give you an overview of the measures that you need to consider when creating a CER for your medical device product.
Download our Clinical Evaluation Report Slide Deck now
Further MDR reading from Acorn Regulatory
A Guide to Drug-Device Combination Products
We have produced a drug-device guide that looks at the issue. It also considers the issue in relation to the changes for drug-device combination products in relation to the Medical Device Regulations. You can download the guide here.
The Responsibilities of the Person Responsible for Regulatory Compliance (PRRC) under MDR
As part of our series of articles looking at some of the changes on the way for medical device regulation under MDR, 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 more here.
Get The 1st Acorn Regulatory Medical Device Regulations Whitepaper
The new medical device regulations (MDR) will come into force in May 2020. In advance of the deadline, companies across the world are working to ensure that their devices will comply with the new regulations. For many companies, there is still much work to do. Also, companies are still actively seeking further information about the regulations and how they will be applied. Read the first whitepaper here
2nd Acorn Regulatory MDR Whitepaper
Our second Acorn Regulatory MDR whitepaper looks at the issues of unique device identifiers, the role of Eudamed under MDR and post-market surveillance. Read the second MDR whitepaper here.
The Medical Device Regulations – MDR – What You Need To Know
The introduction of the new medical device regulations in May 2020 will bring significant changes to the way that we work with medical devices. Our medical device team has been working with many companies to support them for the changeover from the MDD to MDR. During our interactions with these clients, many topics are being raised time and again. Read more here.