medicaldeviceslegal

• About Erik Vollebregt

Tag browsing: guidance

• Erik Vollebregt

  

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• Medicaldeviceslegal tweets

  • EU #MDR extension amendment and #IVDR / # MDR sell-off period removal amendment entered into force now… twitter.com/i/web/status/1… 6 days ago
  • Almost there for the EU #MDR extension and #IVDR removal of sell-off period proposal - accelerated procedure starte… twitter.com/i/web/status/1… 1 month ago
  • The #MDR proposal for extension - “Can the maker repair what he makes?” #medicaldevices #medtech #IVDR #EUMDR… twitter.com/i/web/status/1… 2 months ago
  • #MDR and #IVDR outlook for 2023 - time to restore trust in the EU medical devices regulatory system #medicaldevices… twitter.com/i/web/status/1… 2 months ago
  • Analysis of the #EPSCO meeting regarding #MDR extension and the #MDCG 2022-18 position paper bridging measure for t… twitter.com/i/web/status/1… 3 months ago
  • New #MDCG guidance on authorised representatives and a Dutch competent authority inspection program on authorised r… twitter.com/i/web/status/1… 4 months ago
  • The 2nd edition of The Enriched #MDR and #IVDR is available now! #EUMDR #EUIVDR #medicaldevices #IVDs… twitter.com/i/web/status/1… 5 months ago
  • New EU #productliability rules proposed - a first glance of the impact for the #medicaldevices and… twitter.com/i/web/status/1… 5 months ago
  • MDCG 2022-14, a new position paper by the #MDCG in an attempt to remedy the issues of #notifiedbody capacity.… twitter.com/i/web/status/1… 6 months ago
  • More on the #BlueGuide 2022: analysis of the new elements in Chapter 2 and what they mean for #medicaldevices and… twitter.com/i/web/status/1… 7 months ago

• Most used tags on this blog

  3D printing advertising apps authorised representative Blue Guide borderline Brexit BSi business compliance CE marking Clinical evaluation Clinical investigation clinical trials COCIR commission Council Cybersecurity Dalli data protection Date of Application DIA Euromeeting e-labeling eHealth EN 14155 enforcement ENVI Eucomed Eudamed FCPA FDA GDPR GHTF guidance in vitro diagnostics ivd IVDR ivds labeling Liese M&A market surveillance MDCG MDD MDR MEDDEV medicinal products mhealth mobile medical apps notified bodies notified body patents personal data placing on the market PMA PMS post marketing surveillance product liability quality system Recast reprocessing revision Roth-Behrendt scrutiny seminar software standards subcontractors Swixit telemedicine transition plan transparency Turkxit UDI Unannounced audits vigilance

• Recent comments

  	Axon Lawyers –… on The 2nd edition of The Enriche…
  	Paul Lovell on The MDR proposal for extension…
  	Esther on But weren’t they suppose…

• Most used categories on this blog

  Accessories Advertising Borderline Brexit Business compliance CE marking Clinical evaluation Clinical investigation Data Protection e-commerce eHealth Eudamed FCPA In Vitro Diagnostics IVDR Labeling M&A MDR mHealth Notified Body Personal data Placing on the market PMS Product liability Quality system Recast Software Standards Uncategorized Vigilance

• Archives

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