The European Commission’s Medical Device Coordination Group (MDCG) has published new guidance (MDCG 2025-10) clarifying post-market surveillance (PMS) requirements under Regulation (EU) 2017/745 (Medical Devices Regulation (MDR)) and Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation (IVDR)). The guidance emphasises that PMS should operate as a continuous and proactive process throughout a device’s lifecycle and be fully integrated into manufacturers’ quality management systems. It calls for the active collection and analysis of data, including from scientific literature, registries and the European Database on Medical Devices (EUDAMED), with findings feeding into risk management, clinical evaluation, labelling and corrective actions. Manufacturers must also maintain a device-specific or device-group PMS plan, setting out data collection methods, analysis approaches and predefined thresholds for action.

The Medical Device Coordination Group (MDCG) has published guidance on the qualification of in vitro diagnostic medical devices. Document MDCG 2024-11 reiterates the definition of an in vitro diagnostic medical device (IVD) under Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR), and classifies them into one of four risk classes from Class A (low risk) to Class D (high risk). The classification rules consider factors such as the purpose of the device, the analyte or marker being detected, the risk of false results, and the intended user.

The Medical Device Coordination Group (MDCG) has published medical device guidance and templates on corrective and preventive action (CAPA) plans The voluntary guidance, which is compliant with Regulation (EU) 2017/745 (the Medical Devices Regulation) and Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation) is intended for notified bodies (NBs) when developing CAPA plans to address non-compliances identified during joint assessments, by designating authorities (DAs) when reviewing and providing opinions on NBs’ CAPA plans, and by the joint assessment teams (JATs) when considering CAPA plans and DAs’ opinions. It offers input on corrections, identifying root causes, and verifying the effectiveness of actions taken to remedy non-compliances. This 2024-12 MDCG guidance is meant to serve as a companion guidance to the MDCG’s MDCG 2022-13 guidance titled ‘Designation, re-assessment and notification of conformity assessment bodies and notified bodies’. The MDCG confirmed that the formal list of non-compliances provided by DAs from on-site assessments should determine what should be included in the CAPA plan and restated without modification.

The Medical Device Coordination Group (MDCG) has published position paper MDCG 2025–7, which outlines the implementation timelines for the Master Unique Device Identification Device Identifier (UDI-DI) system applicable to optical medical devices. According to the paper, mandatory implementation is required by 9 November 2026 for contact lenses and by September 2028 for spectacle frames and lenses. The system is designed to simplify device identification by grouping similar products under common identifiers, and manufacturers may choose to implement the system voluntarily before the prescribed deadlines. Additionally, mandatory registration in Eudamed is set to commence in the first quarter of 2026.

The Medical Device Coordination Group (MDCG) has published an updated version of its guidance on the classification of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746. The guidance explains the application of the classification rules in Annex VIII, under which IVDs are classified as classes A, B, C or D according to their intended purpose and inherent risks. Revision 5 makes targeted changes to Rule 7, clarifying that controls without a quantitative or qualitative value assigned by the manufacturer are generally classified as class B. Manufacturers may provide indicative ranges for standalone quality-control materials, but laboratories must determine the target values used routinely. The materials must be limited to monitoring laboratory examination procedures and cannot replace controls required to verify an IVD’s performance. Controls with manufacturer-assigned values are classified under implementing rule 1.6.

The Medical Device Coordination Group (MDCG) has published an updated version of its guidance on the classification of medical devices under Regulation (EU) 2017/745 (Medical Device Regulation (MDR)). The revised guidance provides further clarification on the application of the classification rules set out in Annex VIII MDR. The guidance has been endorsed by Member State representatives within the MDCG but is not legally binding. The update introduces targeted revisions rather than substantive changes to the MDR framework, including updates to general requirements, terminology changes and structural adjustments, notably to Rule 9 on active devices, as well as revisions to tables and practical guidance for several rules, including Rules 2, 8, 9, 10, 12, 16 and 22.

Further to the publication of amending Regulation (EU) 2024/1860 of 13 June 2024 in the European Journal on 9 July 2024, the Medical Device Coordination Group (MDCG) has now released Q&A guidance on the new regulation that amends Regulations (EU) 2017/745, the Medical Devices Regulation (MDR), and (EU) 2017/746, the In Vitro Diagnostics Regulation (IVDR). This is in order to delay the application of the IVDR for certain high risk IVDs preventing diagnostic device shortages across Europe, as well as, bringing forward the gradual roll-out of EUDAMED and create an obligation to inform in case of interruption or discontinuation of supply.

The Medical Device Coordination Group (MDCG) has published guidance on safety reporting in performance studies of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation (IVDR)). The guidance (MDCG 2024-4) outlines the reporting modalities as well as format and sets out its scope of application, which includes post-market performance follow-up (PMPF) studies covered by Article 70(1) of the IVDR that involve procedures additional to those performed under the normal conditions of use of the IVD and where those additional procedures are invasive or burdensome, in case a causal relationship between a serious adverse events and the preceding performance study has been established. The guidance also outlines the procedures for safety reporting in performance studies in the absence of the Eudamed module or when Eudamed is not yet fully functional. The MDCG has also updated its guidance on summary of safety and performance template.

The Medical Device Coordination Group (MDCG) has amended its guidance on the application of Regulation (EU) 2017/745 (the Medical Devices Regulation (MDR)) to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021. The revision ensures the guidance aligns with the general structure of other MDCG guidance documents and takes into account Regulation (EU) 2023/607, which amends the MDR and Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation) as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. The updated guidance confirms that Article 19 of the MDR does not apply to legacy devices, and provides clarification on the application of the transitional provisions to systems and procedure packs covered by a declaration drawn up pursuant to Article 12(2) of Directive 93/42/EEC (the Medical Devices Directive), as well as regarding the requirement to put in place a quality management system in accordance with Article 10(9) of the MDR.

The Medical Device Coordination Group (MDCG) have revised its market surveillance guidance about the medical device surveillance obligations by manufacturers and stakeholders under the transitional provisions of Article 120 of Regulation (EU) 2017/745 (the Medical Devices Regulation (MDR)) as extended on 15 March 2023 by Regulation (EU) 2023/607.

The Medical Device Coordination Group (MDCG) has updated its manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The September 2025 update introduces new sections addressing the qualification and classification of additional products, including red blood cell additive solutions containing adenine, dual action cream with menthol and capsaicin, lactose tablets for vaginal use, microabrasion dental stain removers, medical examination table covers and mobile sterile air systems.

The Medical Device Coordination Group, comprised of representatives from all Member States and chaired by a representative of the European Commission, has endorsed an important revision of the existing guidance for the classification of medical device software under Regulation (EU) 2017/745 (Medical Devices Regulation (MDR)) and Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation (IVDR)). The revised document has updated provisions to reflect the interplay with the European Health Data Space Regulation regarding Electronic Health Record Systems, and it has introduced additional considerations that emphasise the need for a clear intended purpose alongside references to modular MDSW. Clarification has been provided regarding the scope in relation to Annex XVI software, addressing certain software products that, while lacking an inherent intended medical purpose, may be comparable to medical devices in terms of the function and risk profile. Moreover, the guidance includes new examples, notably those pertaining to MDSW intended to treat, and supplementary clarification has been added to Rule 11 (Subrule a), with references and examples for devices intended to prevent the risk of illness. Finally, the revision of Annex IV features the inclusion of a new Class I example.