Notified Bodies for In-Vitro Diagnostic Medical Devices under IVDR
Notified Bodies play a key role in supporting manufacturers to place only safe and compliant in-vitro diagnostic medical devices on the EU Market. They are controlling the manufacturers by carrying out conformity assessment procedures and grant conformity certificates to in-vitro diagnostic medical devices. There are certain expectations that a Notified Body must meet before being designated by the EU Authorities.
A key aspect of their role is to audit the quality management system of the manufacturer and review the technical documentation of IVDs A, B, C, D. Notified bodies will issue EU Technical Documentation Assessment Certificates, EU Quality Management System Certificate, EU Production Quality Assurance Certificate and EU Type Examination Certificates depending on the conformity assessment procedure selected.
All notified bodies which have been designated under Directive 98/79/EC need to be re-designated under the IVDR. Under the IVDR, the requirements that notified bodies must meet have increased drastically. Those notified bodies are also subject to a peer review every 3 years. As a result of this process, we expect that the number of notified bodies designated under the IVDR will be very limited. Notified bodies which have been designated under the IVDR can issue the IVDR conformity assessment certificates. Manufacturer can consult the list of designated notified bodies under the IVDR in the European Commission´s directory of Notified Bodies (NANDO website).
Notified bodies shall conduct surveillance audits on at least an annual basis as well as unannounced audits of manufacturer and where applicable of subcontractors and suppliers.
For class B and class C devices, notified body shall draw up and keep up to date, a sampling plan for the assessment of technical documentation as referred to in Annexes II and III covering the range of such devices covered by the manufacturer’s application. That plan shall ensure that all devices covered by the certificate are sampled over the period of validity of the certificate.
- The Regulation: IVDR 2017/746/EU
- Technical Documentation
- Path to EU Market Entry: Conformity Assessment Procedures
- Authorized Representatives under the IVDR
- Clinical Evidence and Performance Evaluation
- Clinical Performance Studies
- Person Responsible for Regulatory Compliance
Selecting the right Notified Body for your EU Compliance requirements can be a daunting task. Contact us for help in your Notified Body Selection needs!IVDR Inquiries