Medical Device Services
Our medical device regulatory affairs experts have a well deserved reputation for excellence with our global client base. The team is staffed by individuals with significant experience in industry and with national authorities.
The medical devices team, headed by Orla Keane, is working with companies to assist them on numerous issues, some of which are detailed below. Perhaps the biggest issue for medical device companies is the advent of the new medical device regulations (MDR) which will come into force on May 26th 2020. Acorn Regulatory can assist your company in preparing for the new regulations and ensuring ongoing compliance.
Our expert team bring 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:
CE Mark Certification
Obtaining and maintaining CE Mark Certification can be a complex process. Acorn Regulatory will help you at every stage by determining the correct regulatory pathway for your product; including Notified Body selection and appropriate device classification.
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.
We are acknowledged experts in the sector and we act as EU Authorised Representative for many companies. We have also written extensively on the issue on our website. You can read the articles here.
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. 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 can act as your PRRC upon introduction of the new MDR.
ISO 13485 Certification
Gaining ISO 13485 Certification is essential for any organisation in the Medical Device and IVD sector. Our experienced team can devise an appropriate Quality System for you and ensure you meet the ISO 13485 standard.
Post Marketing Surveillance and Device Vigilance
Effective post-market surveillance and vigilance systems are legal requirements of your CE Mark Certification. 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 are 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 experts 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.