1. MDCG 2020-16: Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

Purpose: Defines the classification of in vitro diagnostic medical devices (IVDs) and offers clarifications on the classification rules outlined in Annex VIII of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR).

Highlights:

·   Provides step-by-step guidance on applying risk-based classification for IVD products.

·   Examples of devices in each class (A, B, C, D) are detailed as reference examples.

When do you use this document:  Apply this guidance to ensure accurate classification of your devices, as this determines the conformity assessment pathway  and requirements applicable to achieve compliance to IVDR.

2. MDCG 2022-9: Summary of safety and performance (SSP) template

Purpose: Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturers should have summary of safety and performance (SSP) for class C and D devices, other than devices for performance studies.

Highlights:

·      SSP details the essential elements required in detailed sections, to be included for class C and D devices.

·      Details on the device, target population, usage conditions, clinical evaluation, risks, and post-market surveillance finding summaries are key details in the SSP.

·      SSP ensures alignment with MDR/IVDR requirements and availability via EUDAMED.

When do you use this document:  This guidance document is used in preparation SSP as part of technical documentation for CE marking applicable to Class C and D In Vitro Diagnostic Devices under IVDR Regulation under Article 29 of IVDR 2017/746 and made available in EUDAMED.

3. MDCG 2022-2: Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)

Purpose: This guidance provides clarity on the requirements for clinical evidence under IVDR (EU) 2017/746, ensuring that manufacturers generate sufficient scientific validity, analytical performance, and clinical performance data to demonstrate device safety and effectiveness.

Highlights:

·      Defines Clinical Evidence Requirements explaining how scientific validity, analytical performance, and clinical performance contribute to overall clinical evidence.

·      Clarifies Study Types & Data Sources which are considered acceptable clinical studies, literature reviews, real-world data, and post-market performance data.

·      Supports CE Marking & Market Surveillance guiding manufacturers in collecting and maintaining clinical evidence throughout the device lifecycle to meet IVDR compliance.

When do you use this document: This guidance would help in understanding the clinical evidence requirements for IVD compliance under IVDR (EU) 2017/746. Support manufacturers in preparing Performance Evaluation Plans (PEP), Performance Evaluation Reports (PER), and Post-Market Performance Follow-up (PMPF) for CE marking and post-market surveillance. 

4. MDCG 2022-8: Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC.

Purpose: This guidance details on the expectations of “significant change” in the design or intended purpose of legacy In Vitro Diagnostic (IVD) devices under the IVDR (EU) 2017/746 in the transition period. It helps manufacturers determine whether modifications to existing IVDD-certified devices require a new IVDR conformity
assessment during the transition period.

Highlights:

·      Defines “Significant Changes” with detailed criteria for assessing changes in design, intended purpose, software, and manufacturing processes.

·      Helps manufacturers maintain IVDD certificates (issued before May 26, 2022) while avoiding changes that would require immediate IVDR compliance during the transition period.

·      Offers structured decision-making tools to evaluate whether a change is significant with detailed flowcharts.

·      Explains when manufacturers need to consult a Notified Body for assessing modifications to ensure continuous compliance and device safety.

When do you use this document: This guidance will be used to determine whether a modification to a legacy IVD device (IVDD-certified before May 26, 2022) qualifies as a significant change  under Article 110(3) IVDR. This guidance helps assess changes in design, intended purpose, manufacturing, or software that may require full IVDR compliance and details when Notified Body involvement is necessary during the transition period. 

5. MDCG 2022-6: Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR

Purpose: This guidance helps manufacturers determine whether changes to legacy IVD devices (IVDD-certified before May 26, 2022) are considered “significant changes” under Article 110(3) IVDR. It ensures that manufacturers understand when a modification would require a new IVDR conformity assessment during the transition period.

Highlights:

·      Explains when a change would be considered significant for changes in design, intended purpose, manufacturing process, and software.

·      Helps manufacturers maintain their IVDD certificates without triggering immediate IVDR requirements through
the transition timelines.

·      Supports manufacturers in assessing whether a change requires Notified Body review with detailed decision
flow charts.

When do you use this document:  Manufacturers should use this guidance when assessing the changes in design, intended purpose, manufacturing, or software during transition period especially for qualifying changes as significant or not, under  Article 110(3) IVDR.

6. MDCG 2022-3: Verification of manufactured class D IVDs by notified bodies

Purpose: This guidance provides clarity on the verification process for Class D In Vitro Diagnostic (IVD) devices under the IVDR (EU) 2017/746 with details on the role of Notified Bodies (NBs) in verifying that each batch of Class D IVDs meets regulatory requirements before being placed on the market.

Highlights:

·      Explains the mandatory verification process for each batch of Class D IVDs by a Notified Body, ensuring compliance with IVDR.

·      Specifies when EURLs must be involved in additional batch testing and validation.

·      Defines the steps manufacturers must follow, including documentation submission, sample testing, and
performance review.

·      Details how NBs assess batch compliance before authorizing market release with detailed criteria on NB
verification.

When do you use this document:  Use MDCG 2022-3 when submitting Class D IVDs for batch verification by a Notified Body (NB) before market release under IVDR (EU) 2017/746 and also details potential EU Reference Laboratory (EURL) testing. Manufacturers must follow this process to verify product quality, performance, and safety.