MDR Regulatory Affairs Consultants
MDR (the medical device regulations) will present the most significant changes in the device sector for a generation. Our MDR regulatory affairs consultants are ready to assist your company with any issues related to the new regulations.
The medical devices team is working with companies to get them ready for the changeover on May 26th 2021. New issues to consider such as the introduction of the Person Responsible for Regulatory Compliance and the enhancement of the role of the EU Authorised Representative are providing additional challenges for medical device companies of every size. Our team of MDR regulatory affairs consultants is ready to help your company prepare for MDR.
Our expert team brings their extensive experience of working with hundreds of different devices across all classifications to every project. While each project is unique, we find that some of the most frequently requested services are:
European Authorised Representative Services
All non-EU medical device and IVD manufacturers must appoint a European Authorised Representative. If you are a non-EU manufacturer and wish to market your device in Europe, Acorn Regulatory can act as your EU Authorised Representative. This role has been enhanced in its scope by the new medical device regulations and companies need to ensure that the role of EUAR is ‘fit for purpose’ when the new regulations are introduced in May 2021.
We are acknowledged experts in the sector and we act as EU Authorised Representative for many companies. We can act as EU Authorised Representative on your behalf.
Person Responsible for Regulatory Compliance
The role of the Qualified Person (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. Article 15 of MDR 2017/745 sets out the detail of the person responsible for regulatory compliance. It requires that manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. Acorn Regulatory’s team of MDR specialists can act as your PRRC upon the introduction of the new MDR.
Post Marketing Surveillance and Device Vigilance
Effective post-market surveillance and vigilance systems are legal requirements of your CE Mark Certification. Again, there is now heightened scrutiny as part of the new MDR. If you are unsure of the vigilance reporting requirements in Europe or need help devising a robust post-marketing surveillance strategy, then we can assist your company. We will ensure that you are compliant with the appropriate European legislation.
As referenced above, these are just some of the types of projects that our team of MDR regulatory affairs consultants is asked to work on. If you don’t see what you need here, then please feel free to contact us. Our number is below.
If you have an issue that you would like our medical device regulatory affairs consultants to help you with, then get in touch with us by completing the form below or by calling us on 00353 52 61 76 706.