Regulatory background for IVDs in the European Union
In 2017, the EU In Vitro Diagnostic Devices Regulation (EU IVDR 2017/746) entered into force. The introduction of the IVDR increased regulatory oversight for the majority of the IVD market, which means that, after a transition time, many IVD manufacturers must pursue a new conformity assessment route for their IVDs to remain on the EU market.
The regulatory route for compliance in the EU is determined by the device class of the IVD and the respective conformity assessment chosen by the manufacturer. IVDs are classified as A non-sterile, A sterile, B, C, or D according to their risk profile and intended use. Because a classification system for IVDs is introduced under the IVDR, all IVDs are classified in four (4) risk classes in accordance with implementing and classification rules. All medium and higher risk classes require a conformity assessment conducted by an accredited Notified Body. Under specific conditions, IVD devices still may be marketed in the EU as legacy devices with limited requirements to meet the IVDR; for these legacy devices, different transition periods apply depending on the device class.
To determine how and when your IVD needs to be CE Marked under the new regulations or how long it may be marketed as a legacy device, Pure Global’s regulatory experts can perform a classification assessment. This will help classify your IVD under the new IVDR classification rules and outline the strategy for your IVD device to the EU market.
CE Marking regulatory roadmap under the IVDR
Regardless of classification, all IVDs must fulfill these requirements to obtain CE Marking under the IVDR:
- meet the applicable general safety and performance requirements (GSPRs) set out in Annex I of the IVDR;
- compile a Technical Documentation according to Annexes II and III;
- implement a Quality Management System (QMS) that complies with the requirements in the IVDR;
- implement a Unique Device Identifier (UDI) system for device traceability; and
- retain a European Authorized Representative (EU AR, symbol EC REP) if the manufacturer is not located in the EU.
Class A non-sterile IVDs can self-declare conformity and affix the CE Mark to their device labeling without a Notified Body conformity assessment (audit). However, Class A sterile, B, C, and D IVDs must submit their Technical Documentation for an accredited Notified Body audit; the scope of the audit will expand for devices with higher risk. On completion, the Notified Body will issue an EC Certificate and the CE Mark can be affixed to the device and its labeling. The manufacturer can then sign a Declaration of Conformity (DoC) and register their device with the relevant Competent Authority and/or in EUDAMED.
Key resources for EU MDR CE Marking
Bookmark these links to helpful resources for EU IVDR CE Marking:
