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🚀 The legacy status of your medical devices and IVDs allows you to keep selling your products on the European market. Be aware that the legacy status has an expiration date! What exactly is the legacy status? What are the transition deadlines? What triggers the loss of the legacy status, apart from the end of the grace periods? This article was updated in December 2024. Updates include consideration of MDCG 2021-25 rev. 1. 👉 https://lnkd.in/d6nuAeFj 📢 Follow us for regular updates on medical device regulations! https://lnkd.in/eJ7AmZ9y #medtech #eumdr #ivdr #legacydevice #medicaldevice #ivd #legal Swiss Medtech sitem-insel

📢 Update on Swiss IvDO Amendments The draft amended version of the Swiss Ordinance on In-vitro Diagnostic Devices (SR 812.219, IvDO) has now been published and will enter into force on 1 January 2025. 🔍 What’s New? 1️⃣ Transitional provisions for “legacy” IVDs are aligned with those in the IVDR, as last amended by implementing Reg. (EU) 2024/1860. Read more about legacy devices in our blog article. 🔗 https://lnkd.in/dpbWGh3f 2️⃣ CH-REP labelling is simplified. - IvDO Art. 87 that required CH-REP particulars on the label as of 31-Mar-2025 for IVDs CE-marked under the IVDR that are not for self-testing is replaced by new Art. 15 §9 that permanently allows CH-REP indication on an “accompanying document” (i.e. no date limit) 3️⃣ Key Distinction from EU IVDR: - Switzerland is not adopting Article 10a of the EU IVDR in this amendment to the IvDO. 📄 Currently, the amended ordinance is available in German, French, and Italian. 💡 These updates are important for manufacturers placing IVDs on the Swiss market. Stay tuned as we continue to monitor developments and provide further insights. #SwissRegulations #IVD #Compliance #MedicalDevices #IvDO #CHREP

🚨 Swiss IvDO Update: CH-REP labeling deadline removed for certain IVDs 🚨 💡 Foreign manufacturers, Swiss importers and distributors: take note of this simplified labelling exemption! As part of the upcoming IvDO review (applicable from 1-Jan-2025), CH-REP labelling is simplified as follows: IvDO Art. 87 that required CH-REP particulars on the label as of 31-Mar-2025 for IVDs CE-marked under the IVDR that are not for self-testing is replaced by new Art. 15 §9 that permanently allows CH-REP indication on an “accompanying document” (i.e. no date limit). ⚠️ Important: This labelling exemption does NOT apply to IVDs CE-marked under the IVDR that are intended for self-testing. Such devices must indicate the CH-REP on the label as soon as they are CE-marked under the IVDR. 📄 Explanatory reports on the IvDO amendments (in German, French, and Italian) are available on the Federal Office of Public Health’s (FOPH) website. #RegulatoryUpdates #IVDR #MedTech #IvDO #Switzerland #CHREP #SwissREP 

🚨 Upcoming Amendments to the MedDO and IvDO: Key Updates 🚨 In preparation for the anticipated amendments to the Swiss Medical Devices Ordinance (MedDO) and In Vitro Diagnostic Medical Devices Ordinance (IvDO), two explanatory reports have been published by the Swiss Federal Office of Public Health. While the draft versions of the amended ordinances are not yet available, these reports provide crucial context: 1️⃣ Adaptation of Transitional Arrangements & Addition of Information on the Authorised Representative - Aligned with Reg. (EU) 2024/1860, this report details the extended transitional provisions for the IVDR. - Available in German, French, and Italian. 2️⃣ Product Registration Obligation - Registration in the UDI module of swissdamed will be mandatory starting 1 July 2026. - Registration period: 📅 1 July – 31 December 2026. - Products to be registered: a. All medical devices, systems and procedure packs, and IVDs placed on the Swiss market after 1 July 2026. b. Immediate registration of EU MDR/IVDR-compliant products placed on the Swiss market since 26 November 2017 is required if a Vigilance case needs to be reported. c. No registration required for “legacy” or “old” devices, systems/procedure packs, and IVDs. ⚠️ Translation Misalignment Alert! The French version of the report diverges from the German and Italian versions: DE/IT: “All products placed on the Swiss market after 1 July 2026 must be registered in swissdamed, regardless of where the manufacturer is based.” FR: “Manufacturers are required to register all devices they place on the Swiss market from 1 July 2026, regardless of where their headquarters are located.” This distinction could have significant implications. Stakeholders are advised to review the reports carefully and seek clarity where needed. 📌 Links to further updates will be shared as they become available. Stay tuned! https://lnkd.in/dRGAPH6n #MedDO #IvDO #Swissdamed #MedicalDevices #IVDR #MDR #RegulatoryAffairs #UDI #Compliance #HealthcareInnovation

🚀 The Notified Body is the key stakeholder in the CE-marking process for medical devices and IVDs. Manufacturers who have to involve a Notified Body are faced with a certification period of 6 months to more than 2 years and costs starting at €50,000. This fact makes it necessary to address the issue of notified bodies. What exactly is a Notified Body? When is the involvement of a Notified Body mandatory? Which Notified Body is the most favorable? Where can you find a Notified Body that matches a specific product? In this article you will find answers to these and other questions on the subject of Notified Bodies. 👉 https://lnkd.in/dmWWnDiX 📢 Follow us for regular updates on medical device regulations! https://lnkd.in/eJ7AmZ9y #medtech #eumdr #medicaldevice #notifiedbody #legal #ivdr Swiss Medtech sitem-insel

🔄 Swissmedic updated position on amendments to EC DoCs for “legacy” devices Swissmedic has reversed its position regarding its initial prohibition to amend EC Declarations of Conformity (EC DoCs) for “legacy” devices. In alignment with the revised MDCG 2021-25 rev.1, Swissmedic now accepts amendments to EC DoCs, on the following conditions: ➡️ For "legacy" devices, EC DoCs must have been verifiably drawn up for the first time before the application dates of EU MDR or IVDR.  ➡️ Manufacturers are permitted to document non-significant changes impacting the content of an existing EC DoC (issued under prior legislation) either on a document accompanying the EC DoC or on the EC DoC itself. This updated position ( 🔗 under Swissmedic Medical Devices >> FAQ >> Market access >> Declarations of Conformity) removes unnecessary burden for manufacturers selling “legacy” devices in Switzerland, ensuring they can document minor updates while maintaining compliance. 👉 Get the latest regulatory update: https://lnkd.in/eHs3khty #MedTech #MedicalDevices #RegulatoryUpdates #Swissmedic #EUMDR #IVDR #legacydevices #IVDD #MDD

📢 Swissmedic's New Information Sheet on Clinical investigations of medical devices - Version 6.1 Now Available! Swissmedic has released an updated version (V6.1) of the information sheet on clinical investigations of medical devices. This revision includes important updates for clinical researchers and industry professionals: 🔸 Targeted Study Populations – New Guidance in Box 4, Annex 2: There’s now specific guidance on enrolling a narrower study population with a more favorable benefit-risk profile, allowing for more precise and effective performance evaluations. 🔸 Updated Terminology – Reflecting changes to the Human Research Act Ordinances, the terminology has been revised to ensure consistency with the latest regulatory language. For those conducting or planning Clinical Investigation in Switzerland, these updates are essential. 📊🔬 👇  See full document of V6.1 #MedicalDevices #Swissmedic #ClinicalResearch #RegulatoryUpdates

📢 Swissmedic's New Information Sheet on IVD Performance Studies - Version 5.1 Now Available! Swissmedic has released an updated version (V5.1) of the information sheet on performance studies for in vitro diagnostics (IVD). This revision includes important updates for clinical researchers and industry professionals: 🔸 Targeted Study Populations – New Guidance in Box 4, Annex 2: There’s now specific guidance on enrolling a narrower study population with a more favorable benefit-risk profile, allowing for more precise and effective performance evaluations. 🔸 Updated Terminology – Reflecting changes to the Human Research Act Ordinances, the terminology has been revised to ensure consistency with the latest regulatory language. For those conducting or planning IVD performance studies in Switzerland, these updates are essential. 📊🔬 👉 Get the latest regulatory update: https://lnkd.in/eHs3khty 👇 See full document of V5.1 #IVD #Swissmedic #ClinicalResearch #RegulatoryUpdates #Diagnostics

🔥 The EU Commission just published a 📃Q&A document on the mandatory notification of interruption/discontinuation of supply of medical devices and IVDs that could result in serious harm or risk of serious harm.   This notification shall apply from 📅 10-Jan-2025 and be governed by EU MDR/IVDR Article 10a, which is not yet included in the current consolidated versions of these regulations.   The Manufacturer Information Form that shall be used for such notifications is not yet ready either.   Beware that 💡legacy devices💡 are also concerned.   👇Read the Q&A document:

🚀 Clinical evaluation is the cornerstone of medical device conformity assessment under the EU MDR. As a manufacturer of medical devices, you should therefore develop a strategy for clinical evaluation. But let's start by clarifying your questions. This article covers the most frequent misconceptions regarding clinical evaluation under the EU MDR and intends to help manufacturers understand what is required and how to document it. 👉 https://lnkd.in/dAQvBRbQ 📢 Follow us for regular updates on medical device regulations! https://lnkd.in/eJ7AmZ9y #medtech #eumdr #medicaldevice #clinicalevaluation #legal Swiss Medtech sitem-insel