Who is considered a manufacturer under IVDR?
A manufacturer under the IVDR regulation is any natural or legal person who designs, manufactures, or has an in vitro diagnostic medical device manufactured and places it on the market under their own name or brand. If not established in the European Economic Area, the manufacturer must appoint an authorised representative to act on their behalf
Importance of IVDR compliance for IVD manufacturers
Ensuring compliance with the IVDR regulation is a key requirement for legally placing IVDs on the EU market. Manufacturers must not only adapt documentation and production processes but also actively manage clinical risk and conduct post-market surveillance (PMS).
IVDR classification of IVD devices
IVDR introduces a classification system for in vitro diagnostic devices into classes A, B, C, and D based on risk level. Each class involves different regulatory requirements, notified body involvement, and conformity assessment procedures that must be considered during product design.
Conformity assessment procedures for IVDs
Each IVD class has specific conformity assessment procedures defined by IVDR. Classes C and D require mandatory involvement of a notified body, which includes performance evaluation, technical documentation review, and QMS audits.
IVDR-compliant Quality Management System (QMS)
An IVDR-compliant QMS must cover the entire lifecycle of the device—from design through production to post-market activities. ISO 13485 is the most widely implemented standard, facilitating process documentation, non-conformance handling, and IVDR alignment.
Documentation requirements for IVDs
Technical documentation must include detailed descriptions of device design, intended use, design data, risk analysis, and results of IVD performance evaluation. Completeness and consistency with GSPR are essential for passing conformity assessments.
Performance evaluation under IVDR
IVD performance evaluation involves analytical and clinical validation and PMS/PMPF activities. IVDR requires manufacturers to follow the structure outlined in Annex XIII and XIV, ensuring continuous updates and data integrity.
Person Responsible for Regulatory Compliance (PRRC) under IVDR
Article 15 of IVDR mandates each manufacturer to appoint a PRRC with suitable qualifications and experience. The PRRC oversees documentation, PMS, vigilance, and continuous IVDR compliance.
Manufacturer and device registration in EUDAMED
IVD manufacturers must register in EUDAMED—both as an economic operator and for each product. This includes obtaining an SRN, registering UDI-DI codes, and maintaining up-to-date information in the database.
Post-market surveillance (PMS) and PMPF
The PMS system must effectively gather market data, including complaints, returns, and PMPF findings. For classes C and D, IVDR mandates monitoring real-world performance based on the PMPF plan.
Serious incident and corrective action reporting
IVDR requires incident reporting to competent authorities within strict timeframes. Manufacturers must maintain a documented vigilance system integrated into the quality system to ensure prompt responses and prevent recurrence.
Insurance requirements for IVD manufacturers
IVD manufacturers must provide financial coverage, including a product liability insurance policy to cover damages caused by the device. Coverage must reflect device type and clinical risk level.
Common mistakes made by IVD manufacturers
Frequent mistakes include incorrect classification, lack of performance validation, incomplete QMS, delayed EUDAMED registration, and weak PMS/PMPF systems. These lead to market entry delays or conformity certificate withdrawal.
New obligations under Regulation (EU) 2025/1021
IVDR amendment 2025/1021 mandates active EUDAMED module use, shortens data update deadlines, increases PMPF requirements, and introduces supply monitoring duties. These changes aim to enhance transparency and patient safety.
How Pure Clinical supports IVD manufacturers
Pure Clinical provides full regulatory support for IVD manufacturers, including:
- pre-audit conformity assessments,
- ISO 13485 QMS implementation and IVDR-aligned documentation,
- full performance evaluation execution,
- PMS, PMPF, and vigilance system management,
- communication with notified bodies and competent authorities such as URPL.
With our expertise, IVD manufacturers can accelerate registration and ensure full IVDR compliance.
FAQ
When does IVDR apply to IVD devices?
IVDR applies to all IVDs marketed in the EU, covering the entire lifecycle from design to post-market activities.