{"id":5393,"date":"2025-12-19T15:51:09","date_gmt":"2025-12-19T13:51:09","guid":{"rendered":"https:\/\/teknologiateollisuus.fi\/healthtech\/?post_type=em_event&p=5393"},"modified":"2026-02-02T14:03:44","modified_gmt":"2026-02-02T12:03:44","slug":"eu-medical-device-regulation-latest-developments-and-expert-analysis","status":"publish","type":"em_event","link":"https:\/\/teknologiateollisuus.fi\/healthtech\/events\/eu-medical-device-regulation-latest-developments-and-expert-analysis\/","title":{"rendered":"4.2.2026 | EU Medical Device Regulation (MDR and IVDR): Latest Developments and Expert Analysis\u00a0"},"content":{"rendered":"\n
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Date<\/strong>: 4.2.2026  
Time<\/strong>: 13:00-17:00 (EET) 
Place<\/strong>: Hybrid – Etel\u00e4ranta 10, Helsinki and Teams<\/p>\n<\/div>\n\n\n\n

The Commission has published a proposal on major changes to the MDR and IVDR. Come and hear the latest analysis of the suggested changes in EU regulation, discussion led by Erik Vollebregt<\/strong> and Nelli Karhu<\/strong>.  
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Feedback on the regulations for medical devices and IVDs in the EU has been collected by the Commission during 2025 and there is great political pressure for change. We will hear experts’ views on the ongoing regulatory changes freshly. <\/p>\n\n\n\n

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Agenda<\/h4>\n\n\n\n

12:30 Coffee for on-site participants, Etel\u00e4ranta 10, Helsinki 
13:00 Opening the event \/ Nelli Karhu<\/strong>, Senior Advisor, Healthtech Finland 
13:15 Erik Vollebregt,<\/strong> partner, Axon Lawyers   
14:15 Maria Chiara Orlandi<\/strong>, Legal and Policy Officer, European Commission
14:45 Conversation 
15:00 Break 
15:30 Ajda Mihel\u010di\u010d<\/strong>, Director of Technical & Regulatory Affairs, COCIR   
15:55 Mari Laur\u00e9n-H\u00e4ussler<\/strong>, Senior Officer for Legal Affairs, Ministry of Social Affairs and Health 
16:15 Questions and conversation 
17:00 The event ends <\/p>\n<\/div>\n\n\n\n

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The event will take place on 4 February 2026 in Helsinki, just preceding Labquality Days<\/a>,<\/strong> so participation in both events can be conveniently combined. The event will be hybrid, with a limited number of seats at Etel\u00e4ranta. Please remember to specify whether you will attend remotely or on-site and remember to inform us if you change plans regarding on-site participation. <\/p>\n\n\n\n

You can also meet Erik and Ajda at Labquality Days. If you would like to meet up with Ajda and perhaps introduce your company, please contact Nelli or P\u00e4ivi. <\/p>\n\n\n\n

The event is for HealthTech Finland members<\/a> and separately invited guests.<\/strong><\/p>\n<\/div>\n\n\n\n

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\n\t\t\t\t\t\"Nelli\t\t\t<\/div>\n\t
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Nelli Karhu<\/a><\/h3>\n\t\t\t\t\t\t\tJohtava asiantuntija, Senior Advisor<\/span>\n\t\t\t\t\t\tTerveysteknologia ry<\/span>\n\t\t<\/div>\n\t\t
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\n\t\t\t\t\n\t\t\t\t\t+358 40 182 8312<\/a>\n\t\t\t\t<\/span>\n\t\t\t\t\n\t\t\t\t\tNelli.Karhu@teknologiateollisuus.fi<\/a>\n\t\t\t\t<\/span>\n\t\t\t<\/address>\n\t\t\t