Notified bodies are pivotal in ensuring compliance with medical device regulations within the European Union. A Notified Body is an independent organization that is designated by EU member states to evaluate a medical device’s conformity before these devices enter the market.
These assessments determine whether a device complies with Regulation (EU) 2017/745 on medical devices (MDR) or Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Manufacturers requiring third-party device evaluation must work with a notified body to obtain CE certification.
Responsibilities of Notified Bodies
- Conformity assessments – Notified bodies review technical documentation, perform audits, and verify compliance with applicable regulations. This ensures that medical devices meet the standards for safety, performance, and quality.
- Certification – Once compliance is confirmed, notified bodies issue CE certificates, enabling devices to be marketed within the EU. Certifications are valid for five years, with annual audits conducted to maintain compliance.
- Post-market monitoring – Notified bodies are involved in ongoing evaluations, ensuring continued conformity. They may conduct unscheduled audits or assess technical documentation updates as needed.
Designation and Monitoring
National authorities designate notified bodies based on strict criteria, including organisational structure and quality management capabilities. These bodies are closely monitored to maintain impartiality and adherence to EU standards. Their annual reports are also made public.
Ensure Compliance with Expert Guidance
Are you a medical device manufacturer who needs help in adhering to medical device regulations and understanding notified bodies for medical devices? Contact Vicki Partridge for expert advice on certification and regulatory compliance. Call +61 7 55295508.