EU CE Marking Approval for IVDs
All IVDs must obtain CE Marking to be legally sold in the European Union.
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:
Frequently
Asked Questions
What are the QMS requirements under IVDR?
As stated, all IVDs require a QMS under the IVDR, though requirements vary slightly by classification. Class A non-sterile devices must implement a minimal QMS that meets the requirements of the IVDR, but do not require an audit. All other classes must implement a full QMS and undergo a Notified Body audit of their QMS. Most manufacturers implement a QMS to EN ISO 13485, as it fulfills the general requirements, though EN ISO 13485 certification is not required under the IVDR.
What is a Notified Body?
Notified Bodies (NBs) are accredited organizations that evaluate medical devices and IVDs and issue EC certificates for CE Marking. Your NB will perform a conformity assessment review of your Technical Documentation, as well as an audit of your QMS and Technical Documentation, to ensure your device meets the safety and efficacy requirements. You must choose a Notified Body accredited by Competent Authorities under the IVDR to perform your conformity assessment review.
I have a legacy IVD. When do I have to obtain an IVDR CE certificate?
The regulatory infrastructure and the IVD industry have struggled with the transition to the IVDR, causing multiple delays and amendments to implement extra transition timelines. All legacy devices, particularly high-risk devices, have final transition deadlines beginning in 2027. Further, all legacy IVD devices must have an IVDR-compliant QMS in place by May 2025 and Class A non-sterile devices are expected to already be in full compliance with the IVDR since 26th May 2022. The final deadlines to obtain IVDR CE Marking, i.e., the end of the transition period, for each classification is as follows:
- Class D: December 31, 2027
- Class C: December 31, 2028
- Class B: December 31, 2029
- Class A sterile: December 31, 2029
Manufacturers must lodge an application with an NB two and a half years prior to their official transition deadline. For Class D, the application deadline is May 26, 2025. This step is intended to allow enough time for the Notified Body conformity assessment, which is expected to take between 12 and 24 months, depending on the risk class and quality of data provided. This timeline can be significantly reduced through a well-structured and organized QMS and Technical Documentation. The sooner you prepare for this transition, the more likely it will be that you pass this Notified Body conformity assessment without delay and remain on the EU market.
What is a companion diagnostic (CDx) device?
In the IVDR (Article 2(7)), a companion diagnostic is defined as “a device which is essential for the safe and effective use of a corresponding medicinal product to (a) identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or (b) identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product.” The IVDR classifies companion diagnostics as Class C according to Rule 3(f), which requires a Notified Body intervention. General conformity assessment procedures for the CDx as outlined in IVDR Article 48 include Annexes IX to XI. For CDx, the Notified Body shall consult a national competent authority (NCA) designated by the member states in accordance with Directive 2001/83/EC of the European Parliament and of the Council or the European Medicines Agency (EMA), as applicable. The EMA/NCA will review the Summary of Safety and Performance of the CDx with an assessment period of 60 days.
