Key Terms
- In vitro diagnostic medical device (IVD)
- A medical device — reagent, kit, instrument, apparatus, or software — intended for in vitro examination of specimens derived from the human body to provide diagnostic, monitoring, or compatibility information [Art. 2(2)].
- Performance evaluation
- A continuous process to demonstrate the scientific validity, analytical performance, and clinical performance of an IVD, documented in a performance evaluation report that must be updated throughout the device lifetime [Art. 56, Annex XIII].
- Companion diagnostic
- A device essential for the safe and effective use of a corresponding medicinal product, used to identify patients likely to benefit from treatment or those at increased risk of serious adverse reactions [Art. 2(7)].
- Unique Device Identifier (UDI)
- A series of numeric or alphanumeric characters created through internationally accepted standards, enabling unambiguous identification of specific devices on the market, comprising a device identifier (UDI-DI) and a production identifier (UDI-PI) [Art. 2(15), Art. 24].
- Notified body
- A conformity assessment body designated by a Member State under Articles 32-38 to carry out third-party conformity assessment activities, including technical documentation review and quality management system audits [Art. 32].
- Post-market surveillance (PMS)
- A proactive, systematic process by which manufacturers gather, record, and analyse data on device quality, performance, and safety after market placement, forming an integral part of the quality management system [Art. 78].
- Periodic safety update report (PSUR)
- A report required for Class C and D devices summarising PMS data analysis, benefit-risk conclusions, sales volume estimates, and main post-market performance follow-up findings, updated at least annually [Art. 81].
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Frequently Asked Questions
Which IVD risk class does my device fall into under the IVDR?
The IVDR introduces four risk classes (A, B, C, D) based on Annex VIII rules. Class D covers high-risk devices such as blood-borne transmissible agent detection for transfusion safety. Class C includes companion diagnostics, cancer screening devices, and genetic testing. Class B is the residual category, and Class A covers general laboratory products and specimen receptacles [Art. 47, Annex VIII].
What changed compared to the old IVD Directive 98/79/EC?
The Directive used a list-based classification (Annex II List A/B plus self-certification). The IVDR replaces this with a rule-based four-class system where the vast majority of devices now require notified body involvement. Performance evaluation requirements are significantly expanded, and manufacturers must implement a structured post-market surveillance system [Art. 47, Art. 56, Art. 78].
Can I still sell legacy IVDs under the old Directive during the transition?
Yes, subject to strict conditions under Art. 110(3c): no significant changes in design or intended purpose, no unacceptable risk, QMS in place since 26 May 2025, and formal application plus signed agreement with a notified body by the staggered deadlines. Market placement cutoffs are 31 December 2027 (Class D), 31 December 2028 (Class C), and 31 December 2029 (Class B/A sterile) [Art. 110(3a)-(3c)].
What are the incident reporting deadlines under the IVDR?
Manufacturers must report serious incidents to competent authorities: within 2 days for serious public health threats, within 10 days for events involving death or unanticipated serious deterioration, and within 15 days for all other serious incidents. Initial reports may be incomplete, but must be followed by complete reports [Art. 82(3)-(7)].
Do I need a notified body for Class A devices?
Class A devices that are non-sterile and do not have a measuring function may self-certify without notified body involvement. However, Class A sterile devices and Class A devices with a measuring function require notified body assessment of the relevant aspects [Art. 48(2)-(3)].
What is required for a performance evaluation under the IVDR?
Manufacturers must demonstrate scientific validity, analytical performance, and clinical performance through a structured performance evaluation following Annex XIII Part A. Clinical performance studies may be required unless justification is provided for relying on other data sources. The performance evaluation report must be updated throughout the device lifetime, at least annually for Class C and D [Art. 56].
What qualifications must the person responsible for regulatory compliance have?
They need either a university degree in law, medicine, pharmacy, engineering, or a relevant scientific discipline plus at least one year of professional experience in regulatory affairs or QMS for IVDs, or alternatively four years of such professional experience. SMEs may use an external person permanently at their disposal instead of an in-house employee [Art. 15(1)-(2)].
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