Our medical device specialists are some of the most experienced in the regulatory sector. They have gained a wealth of experience working with industry leaders and in national competent authorities. Our team of specialists can become your team and they can assist you with any regulatory issues that you might need assistance with.
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. We have a wide range of experience in different product technologies and can advise you on the pre-clinical and clinical data needed for CE Mark Certification. Our team of medical device experts will prepare your Technical File and obtain CE Mark Certification for your product.
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. Working with Acorn Regulatory as your EU Authorised Representative has many advantages:
- We deliver a fast, efficient service in obtaining Certificates of Free Sale from the Irish Medicines Board on your behalf.
- Certificates of Free Sale issued by the Irish Medicines Board are valid for 5 years, gaining you an advantage and reducing your workload in global product re-registration cycles.
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.
Companies seeking to market a medical device in Europe need to create and maintain a Clinical Evaluation Report (CER).
The increase in responsibilities of the manufacturer as a result of recent changes to regulations has meant that, increasingly, manufacturers are asking us to work with them to create Clinical Evaluation Reports (often called Clinical Evaluation Reviews) for their products.
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, call Acorn Regulatory today. We will ensure that you are compliant with the appropriate European legislation.