The latest updates from the medical sector and MeDev news.
โ What is it? ISO 10993-3:2026 is the standard that specifies how to assess whether medical devices can cause genotoxicity (genetic damage), carcinogenicity (cancer), and reproductive and developmental toxicity. โก The most important change: You used to assess with default testing. Now: chemistry and risk analysis first, tests only if you justify them.
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๐จ Was your IVD self-declared under Directive 98/79/EC and is it now class C? ๐ You have until 26/09/2026 to sign the contract with a Notified Body. โ Without a contract: the transitional period ends and you lose market access until you obtain the IVDR certificate. โ With a contract: you can keep placing it on the market until 31/12/2028.
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Electronic health record systems require CE marking through self-certification. Requirements in Annex II, documentation kept for 10 years. Applicable from March 2027.
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Since Regulation (EU) 2021/2226 entered into force in early 2022, manufacturers have been able, under certain conditions, to provide instructions for use for medical devices in electronic format (eIFU). With Regulation (EU) 2025/1234, the European Commission has further developed the original framework and extended the scope of the eIFU requirements.
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MDCG position paper: "UDI assignment between manufacturers and distributors", July 2026.
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The European Commission has updated the MIR (Manufacturer Incident Report) form used by medical device manufacturers to report serious incidents to competent authorities, as required by Article 87 of Regulation (EU) 2017/745 (MDR). Version 7.3.1 is mandatory as from 1 May 2026, and only the versions published from December 2025 onwards are accepted.
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RECOPS (Registro de Comercializaciรณn de Productos Sanitarios, the Spanish Registry of Marketed Medical Devices) is the new AEMPS platform operational since 28 May 2026, and the inclusion of devices under the MDR is mandatory since 15 June 2026
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EUDAMED 2.27.0 released, the version that becomes mandatory from 28 May 2026 for SRN and new devices โ 28 Nov 2026 for all devices: we help you through the process โฆ
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Manufacturers and importers (under their critical verification duty) must focus on entering their devices in the UDI/DEV module: there is no time to lose if your device is under 'legacy' status โ and if it is not, you are already late!!!!.
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Manufacturers must focus on completing the ACT and UDI/DEV modules, which are their direct responsibility: There is no more time to lose.
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MedTech Europe* makes available a Manufacturer Declaration template to facilitate manufacturers' declarations with respect to Regulation (EU) 2023/607 and: The validity of certificates issued for Legacy Devices under Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) or Council Directive […]
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The European Commission publishes the 'Confirmation Letter' template required to apply the extended transitional periods of Regulation (EU) 2023/607
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The MHRA announces an additional extension of the UKCA marking standstill period
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An ๐๐ฝ๐ฑ๐ฎ๐๐ฒ ๐ผ๐ณ ๐๐ต๐ฒ ๐ ๐๐๐ ๐ฎ๐ฌ๐ฎ๐ฌ-๐ฏ ๐๐๐ถ๐ฑ๐ฎ๐ป๐ฐ๐ฒ on ๐๐ถ๐ด๐ป๐ถ๐ณ๐ถ๐ฐ๐ฎ๐ป๐ ๐ฐ๐ต๐ฎ๐ป๐ด๐ฒ๐ ๐ถ๐ป ๐ฟ๐ฒ๐น๐ฎ๐๐ถ๐ผ๐ป ๐๐ผ ๐๐ต๐ฒ ๐๐ฟ๐ฎ๐ป๐๐ถ๐๐ถ๐ผ๐ป๐ฎ๐น ๐ฝ๐ฟ๐ผ๐๐ถ๐๐ถ๐ผ๐ป ๐ผ๐ณ ๐๐ฟ๐๐ถ๐ฐ๐น๐ฒ ๐ญ๐ฎ๐ฌ ๐ผ๐ณ ๐๐ต๐ฒ ๐ ๐๐ฅ has been published for medical devices certified under the MDD or AIMDD.
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๐ข The Spanish Agency of Medicines and Medical Devices (AEMPS) announces the update of the previous Instruction PS1/2022 to include requirements established in Real Decreto 192/2023 (Royal Decree) of 21 March, regulating medical devices.
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Questions and Answers: The Commission proposes an extension of the transitional periods for the application of the Medical Devices Regulation
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I want to manufacture or import a product, butโฆ is it a medical device? Or is it an in vitro diagnostic medical device? How can I tell?
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It is RD 192/2023 of 21 March 2023. The Real Decreto (Royal Decree) enters into force tomorrow (23 March).
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The Council of Ministers approves the Real Decreto (Royal Decree) regulating medical devices. This rule replaces the one in force since 2019 and its purpose is to adapt national legislation on medical devices in line with the provisions of the European Union Regulation, which has been applied since 2021.
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Regulation (EU) 2023/607 has entered into force, extending the validity of certificates issued in accordance with Directives 90/385/EEC and 93/42/EEC.
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MDCG: new MDCG 2022-18 Position paper on the application of Article 97 MDR to legacy devices whose MDD or AIMDD certificate expires before the issuance of an MDR certificate
Read moreMDCG 2022-17 on hybrid audits. Guidance on โhybrid auditsโ carried out on-site and remotely
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