What is IVDR?

Regulation (EU) 2017/746 (IVDR) is the core legal act governing the conformity assessment, certification, and post-market surveillance of in vitro diagnostic (IVD) devices in the European Union. It replaces Directive 98/79/EC (IVDD) and became fully applicable on 26 May 2022. The IVDR aims to harmonize requirements across all EU member states and enhance safety for both patients and users by tightening standards for quality, performance, and oversight of IVD devices.

IVDR vs. IVDD – Key Differences

Compared to the IVDD, the IVDR introduces more rigorous and comprehensive requirements. Key changes include:

  • implementation of a risk-based classification system with four classes: A, B, C, D,
  • mandatory analytical and clinical performance evaluation for most devices,
  • mandatory involvement of a Notified Body for Classes B, C, and D,
  • registration in EUDAMED and implementation of the UDI system,
  • requirement to appoint a Person Responsible for Regulatory Compliance (PRRC).

Classification of IVD Devices under IVDR

The IVDR introduces a risk classification system based on the intended purpose and potential public health impact. The risk classes are:

  • Class A: lowest risk (e.g., laboratory equipment),
  • Class B: moderate risk (e.g., general diagnostic tests),
  • Class C: high risk (e.g., cancer screening assays),
  • Class D: highest risk (e.g., HIV, HCV tests, blood screening products).

The classification determines the conformity assessment procedure and whether Notified Body involvement is required.

Certification of IVD Devices under IVDR

The certification process for an IVD device includes the following stages:

For non-sterile Class A devices, a self-declaration of conformity is sufficient. Notified Body assessment is mandatory for Classes B, C, and D.

Technical Documentation Requirements for IVDs

Technical documentation must include:

  • device description, intended use, and mechanism of action,
  • results of analytical and clinical performance studies,
  • risk analysis and benefit-risk evaluation,
  • evidence of compliance with general safety and performance requirements,
  • information on manufacturing processes and validations,
  • data from PMS and PMPF as part of post-market surveillance.

Role of PRRC under IVDR

Manufacturers must appoint a Person Responsible for Regulatory Compliance (PRRC). This person is responsible for maintaining the technical documentation, overseeing post-market surveillance, and supervising performance evaluation processes.

UDI System for IVD Devices

The Unique Device Identification (UDI) system assigns each IVD a unique identifier consisting of a device and production identifier. UDI improves traceability, supports recalls, and is mandatory for all Class B, C, and D devices.

EUDAMED and IVD Registration

EUDAMED is the European database containing information on devices, manufacturers, certificates, and incidents. Registration is mandatory and includes UDI, vigilance, certification, and performance study modules.

Manufacturer Obligations under IVDR

IVD manufacturers must:

  • maintain a quality management system for the entire product lifecycle,
  • implement PMS and PMPF activities,
  • apply risk management and performance evaluation methodologies,
  • keep technical documentation complete and up to date,
  • register devices and report incidents in compliance with IVDR.

Software-Based IVD Devices (SaMD)

The IVDR also covers software-based IVDs, including applications analyzing genetic data or imaging outputs. These require validated performance evaluation, algorithm risk analysis, and compliance with software standards such as IEC 62304.

IVDR Implementation Timeline

Although IVDR became fully applicable on 26 May 2022, transitional provisions are in place for devices previously certified under IVDD:

  • Class D – until 26 May 2025,
  • Class C – until 26 May 2026,
  • Class B and sterile Class A – until 26 May 2027.

Compliance with PMS, PMPF, and technical documentation updates is required throughout the transition period.

How Pure Clinical Can Help You Comply with IVDR

Pure Clinical supports manufacturers in preparing for IVDR compliance through:

  • development and review of technical documentation,
  • design of performance evaluation and PMPF plans,
  • risk analysis and PMS strategy development,
  • support in communication with Notified Bodies and competent authorities.

We have experience with Class B, C, and D devices, including molecular, immunological, genetic tests, and software-based diagnostics (SaMD).

FAQ

Which IVD devices require involvement of a Notified Body during certification?

Most IVD devices classified as Class B, C, or D under IVDR require conformity assessment by a Notified Body. Only non-sterile Class A devices are exempt and may follow self-certification.

What are the main documents required in the IVD certification process?

Manufacturers must submit technical documentation including performance evaluation data, risk analysis, design and manufacturing details, PMS/PMPF plans, and evidence of compliance with General Safety and Performance Requirements (GSPRs).

What happens if an IVDD certificate expires before the IVDR certificate is granted?

Once the IVDD certificate expires, the device can no longer be placed on the EU market unless a valid IVDR certificate is obtained. Transition provisions require maintaining continuous certification to avoid market disruption.

Does every IVD device require clinical investigations?

Not all IVDs require new clinical investigations. Manufacturers can use existing clinical and analytical data if sufficiently robust. However, a performance evaluation (including clinical performance) is mandatory for all devices.

Are laboratory tests used only for research purposes subject to IVDR?

No. Research Use Only (RUO) tests are exempt from IVDR as long as they are not intended for clinical diagnostic purposes or placed on the market for such use.

How often should IVD technical documentation be updated?

Technical documentation must be reviewed and updated regularly, especially after significant design changes, performance findings, or updates from PMS and PMPF activities

Are all clinical laboratories required to comply with IVDR?

Not necessarily. Laboratories developing in-house tests (LDTs) may be exempt under Article 5(5) of IVDR if they meet strict institutional and risk-related conditions. Commercial labs must comply fully.

What is the difference between PMS and PMPF in IVDR?

PMS (Post-Market Surveillance) monitors real-world device performance. PMPF (Post-Market Performance Follow-up) is a proactive part of PMS for IVDs.