What is IVDR and What Changed?

IVDR replaces the IVDD (In Vitro Diagnostic Medical Devices Directive) which had governed EU IVD regulation since 1998. The key changes are profound: (1) Risk-based classification with a new 4-class system (A, B, C, D) replacing the IVDD's Annex II/self-declaration approach — dramatically reclassifying many IVDs to higher risk classes requiring Notified Body involvement; (2) Explicit requirement for clinical evidence from performance studies rather than literature alone; (3) Mandatory Notified Body involvement for Class B, C, and D devices — previously, most IVDs could self-certify without NB review; (4) EUDAMED registration requirements; (5) Post-market performance follow-up (PMPF) as a mandatory ongoing activity.

The New IVDR Classification System

IVDR uses a 4-class risk system: Class A (lowest risk — general laboratory instruments, sample containers, staining reagents) — self-declaration, no NB required. Class B (moderate risk — most clinical chemistry, haematology, and general diagnostics) — Notified Body QMS assessment required. Class C (high risk — HIV, hepatitis, companion diagnostics, HbA1c) — Notified Body QMS plus technical documentation assessment required. Class D (highest risk — blood group testing, NAT for transfusion, CJD) — most rigorous pathway including NB review of performance studies. The reclassification from IVDD to IVDR is the most disruptive element for Turkish IVD manufacturers: many products previously self-declared as general IVDs are now Class B or C under IVDR, requiring Notified Body involvement for the first time.

Transition Timelines: Where Are We Now?

IVDR has been fully applicable since May 2022. The EU Commission extended transition periods for legacy devices: Class D devices — legacy certificates valid until May 2025 (most have now been renewed or withdrawn); Class C devices — legacy certificates valid until May 2026; Class B and Class A sterile devices — legacy certificates valid until May 2027. Importantly, to benefit from the transition period, devices must have been lawfully placed on the EU market under IVDD before May 2022 and the manufacturer must be actively working toward IVDR certification. Turkish IVD manufacturers with Class C devices have a very tight window — May 2026 is the deadline for Class C legacy certificates.

Clinical Evidence: The Biggest Compliance Challenge

IVDR's clinical evidence requirements are the most significant compliance challenge for most manufacturers. Under IVDR, clinical evidence means: analytical performance data (accuracy, precision, linearity, interference, reference intervals) documented in an Analytical Performance Report, and clinical performance data (sensitivity, specificity, positive and negative predictive values) documented in a Clinical Performance Report, either from prospective clinical performance studies, from retrospective analysis of archived samples with defined inclusion criteria, or from systematic literature review where appropriate. For Class C devices, the clinical performance report must be reviewed by the Notified Body. Performance studies may need to be conducted in multiple EU member states to demonstrate performance across the intended patient population.

Post-Market Performance Follow-Up (PMPF)

IVDR requires manufacturers to maintain a Post-Market Performance Follow-Up (PMPF) system — ongoing active collection of performance data from the field. PMPF includes: monitoring scientific literature for new information affecting device performance, analysis of real-world performance data from customers and distributors, participation in external quality assurance (EQA) programmes, and where indicated, formal post-market performance studies. PMPF data feeds into annual Summary of Safety and Performance reports (for Class C and D devices) and must be used to update Performance Evaluation Reports. This is a continuous obligation, not a one-time activity.

Practical Steps for Turkish IVD Manufacturers

Turkish IVD manufacturers should immediately: (1) Classify all IVD products under the IVDR classification system — compare against IVDD classification to identify reclassifications; (2) Identify which products require Notified Body involvement under IVDR; (3) Contract with an accredited IVDR Notified Body (note: fewer NBs are accredited for IVDR than for MDR — early contracting is essential as NB capacity is constrained); (4) Commission analytical and clinical performance studies where existing data is insufficient for IVDR requirements; (5) Update technical documentation to IVDR structure (replacing IVDD technical files); (6) Establish PMPF systems and EUDAMED registration processes.

Conclusion

IVDR is the most significant regulatory compliance challenge facing Turkish IVD manufacturers in the EU market. The combination of reclassification, new clinical evidence requirements, mandatory NB involvement, and PMPF obligations represents a step-change in regulatory burden. Turkish manufacturers who engage with IVDR compliance proactively — particularly those with Class C products facing the May 2026 deadline — will protect their EU market access. Those who delay face the real risk of being unable to sell their products in the EU's largest and most valuable markets.