Table of contents
IVDR Regulation 2017/746
The IVDR is the legal act governing the placing on the market and the putting into service of in vitro diagnostic medical devices in the EU. Its objective is to ensure a high level of protection of the health of patients and users and to harmonise the rules applicable to IVDs throughout the Union.
Key requirements of IVDR 2017/746
The key requirements of the IVDR include, among others:
- Classification of IVDs, (A, B, C, D) according to the risk to the patient and the risk to public health.
- The obligation to draw up technical documentation containing, among others, risk management documentation and the performance evaluation together with clinical evidence.
- Conformity assessment procedures, including the involvement of a notified body for class A devices placed on the market in sterile condition and for class B, C and D devices.
- Post‑market surveillance (PMS) and post‑market performance follow‑up.
- Traceability and labelling of the device, in particular by means of the Unique Device Identifier (UDI).
Classification of IVD Devices
IVDs are classified into four risk classes according to the risk to the patient and the risk to public health, in accordance with the rules set out in Annex VIII to the IVDR:
- Class A – lowest risk (e.g. a specimen receptacle).
- Class B – moderate risk (e.g., a pregnancy self-tests)
- Class C – high risk to the patient(e.g. an assay for a tumour marker (PSA)).
- Class D – highest risk • to the patient and to public health (e.g. an assay for detecting HIV in blood donations).
Conformity assessment for IVDs
The conformity assessment procedure depends on the classification of the device:
- For Class A devices, the manufacturer draws up the technical documentation itself and issues the EU declaration of conformity. For class A devices placed on the market in sterile condition, the involvement of a notified body is mandatory in relation to the aspects concerning the establishment, securing and maintenance of sterile conditions.
- For class B, assessment of the quality management system and assessment of the technical documentation of at least one representative device per generic device group.
- For class C, assessment of the quality management system and assessment of the technical documentation on a representative basis; for companion diagnostics, the notified body seeks a scientific opinion from the European Medicines Agency or from the competent medicinal products authority.
- For class D, assessment of the quality management system and assessment of the technical documentation of every device, with the involvement of an EU reference laboratory; where no common specifications are available, the notified body seeks the views of an expert panel on the performance evaluation report.
Technical Documentation for IVDs
The technical documentation drawn up in accordance with Annexes II and III to the IVDR should contain, among others:
- The device description and specification, including its variants and accessories.
- The information to be supplied by the manufacturer (label and instructions for use).
- Design and manufacturing information.
- Information demonstrating conformity with the general safety and performance requirements.
- Information on the benefit‑risk analysis and on risk management.
- Verification and validation results, including stability testing and software validation.
- The performance evaluation plan and report together with the clinical evidence: scientific validity, analytical performance and clinical performance.
- Post‑market surveillance documentation, including the post‑market surveillance plan and the post‑market performance follow‑up (PMPF) plan.
Post‑Market Surveillance (PMS)
Post‑market surveillance is the ongoing monitoring of IVDs after they are placed on the market. Manufacturers must collect data on safety and performance, analyse adverse incidents, update risk assessments and implement corrective actions. For example, a manufacturer of a diagnostic test may track user‑feedback and incident reports to maintain compliance with IVDR and ensure continued product safety.Once a device has been placed on the market, the manufacturer carries out systematic surveillance of its safety and performance: it collects and analyses data from the market, updates risk management and the performance evaluation, and implements corrective actions. Manufacturers of class A and class B devices draw up a post‑market surveillance report, while manufacturers of class C and class D devices draw up a periodic safety update report (PSUR), which is updated annually. For class C and class D devices, a summary of safety and performance (SSP) is also drawn up. Serious incidents and field safety corrective actions (FSCA) are subject to reporting under the vigilance system.
Identification and traceability of IVDs
Each device is assigned a Unique Device Identifier (UDI), composed of a device identifier (UDI‑DI) and a production identifier (UDI‑PI) covering the lot or batch number, the serial number, the manufacturing date or the expiry date. The manufacturer also assigns a Basic UDI‑DI, which links the device to its certificates and documentation, and registers the device and itself as an economic operator in the EUDAMED database. The UDI system makes it possible to identify a batch rapidly in the event of an incident or of a withdrawal of the device from the market.
Certification process for IVDs under IVDR 2017/746
The certification assessment of IVDs takes place in several stages and requires close cooperation between the manufacturer and the notified body:
- Application: submission of the application together with information on the device and its intended purpose.
- Application review: verification of the classification of the device, of the scope of the notified body’s designation and of the selected conformity assessment procedure.
- Quotation and contract: preparation of the quotation and signature of the contract for carrying out the conformity assessment.
- Planning: establishing the schedule and appointing an assessment team with the appropriate competence.
- Assessment of the technical documentation: to an extent depending on the class of the device; for class D devices, with the involvement of an EU reference laboratory.
- Assessment of the quality management system: review of the system documentation, followed by an audit at the manufacturer’s premises and, where necessary, at its subcontractors and crucial suppliers.
- Decision: taken by persons not involved in the assessment; issue of the certificate or refusal to issue it, together with the reasons.
- Surveillance: surveillance assessment at least once every 12 months and unannounced audits. The certificate is issued for a period not exceeding 5 years; its extension requires recertification.
GCB offers an independent and impartial certification process. We provide information on the requirements of the Regulation and on the course of the conformity assessment procedure. In accordance with Annex VII to the IVDR, we do not provide advisory or consultancy services to manufacturers, which guarantees the independence and impartiality of the assessments carried out.
