Manufacturers shall report, by means of the electronic system referred to in Article 92, any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side-effects that could have a significant impact on the benefit-risk analysis referred to in Sections 1 and 8 of Annex I and which have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits. The significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents in respect of the device, or category or group of devices, in question during a specific period as specified in the technical documentation and product information.
The manufacturer shall specify how to manage the incidents referred to in the first subparagraph and the methodology used for determining any statistically significant increase in the frequency or severity of such incidents, as well as the observation period, in the post-market surveillance plan referred to in Article 84.
2.
The competent authorities may conduct their own assessments on the trend reports referred to in paragraph 1 and require the manufacturer to adopt appropriate measures in accordance with this Regulation in order to ensure the protection of public health and patient safety. Each competent authority shall inform the Commission, the other competent authorities and the notified body that issued the certificate, of the results of such assessment and of the adoption of such measures.
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Related guidance (17)
Current English catalogue entries that refer to Article 88. Guidance is non-binding and kept separate from the regulation text.
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MDCG 2019-9 - rev.1Summary of safety and clinical performanceMarch 2022⌄
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MDCG 2021-13 rev.1Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDRJuly 2021⌄
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MDCG 2021-1 rev.1Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functionalMay 2021⌄
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MDCG 2022-16Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746October 2022⌄
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MDCG 2019-16 rev.1Guidance on cybersecurity for medical devicesJuly 2020⌄
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MDCG 2020-14Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR)August 2020⌄
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MDCG 2019-7 - rev.1Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC)December 2023⌄
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Show all 17 guidance documentsShow only the first 8
MDCG 2025–10Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devicesDecember 2025⌄
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MDCG 2024-1Device Specific Vigilance Guidance (DSVG) TemplateJanuary 2024⌄
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MDCG 2024-1-1DSVG 01 on Cardiac ablationJanuary 2024⌄
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MDCG 2024-1-2DSVG 02 on Coronary stentsJanuary 2024⌄
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MDCG 2024-1-3DSVG 03 on Cardiac implantable electronic devices (CIEDs)January 2024⌄
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MDCG 2024-1-4DSVG 04 on Breast implantsJanuary 2024⌄
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MDCG 2024-1-5DSVG 05 on Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary IncontinenceJune 2024⌄
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MDCG 2023-3 rev.2Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746January 2025⌄
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MDCG 2022-21Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745December 2022⌄
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