On 3 April 2020, NAMSA’s EU Regulatory experts provided a critique of The European Commission’s proposal to delay the date of MDR application by one year, found here. Crucially, there …
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Mapping QMS to EU IVDR Requirements: 3 Key Takeaways to Effectively Strategize QMS Implementation
The European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) 2017/745 has introduced a number of Quality Management System (QMS) requirements for In Vitro Diagnostic (IVD) manufacturers. Most of the self-declared …
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Important elements revolve around maintaining quality, performance and safety throughout the product lifecycle. As the new In Vitro Diagnostic Regulation (IVDR) replaces the current In Vitro Diagnostic Directive (IVDD) in …
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Thursday, April 9th, 2020 at 10:04am
On 7 April, the European Council provided feedback regarding the European Commission’s proposal to delay the MDR date of application, now providing more clarity on Article 120(3). What does this mean for your EU medical device operations? We break it down: https://t.co/QFy2ZmjUR2 https://t.co/lROPVkYBDz
On 7 April, the European Council provided feedback regarding the European Commission’s proposal to delay the MDR date of application, now providing more clarity on Article 120(3). What does this mean for your EU medical device operations? We break it down: https://t.co/QFy2ZmjUR2 https://t.co/lROPVkYBDz
Thursday, April 9th, 2020 at 5:30am
NAMSA is proud to have partnered with several global IVD Sponsors for EUA assay submissions to combat COVID-19. IVD Sponsors seeking expedited EUA development of Serology or Molecular assays, are encouraged to reach out to us today to learn more: https://t.co/17kIbJzhRU https://t.co/xbgvtkDKnN
NAMSA is proud to have partnered with several global IVD Sponsors for EUA assay submissions to combat COVID-19. IVD Sponsors seeking expedited EUA development of Serology or Molecular assays, are encouraged to reach out to us today to learn more: https://t.co/17kIbJzhRU https://t.co/xbgvtkDKnN
Wednesday, April 8th, 2020 at 6:02am
The COVID-19 pandemic is threatening the validity of many #clinicalresearch programs that are currently underway. View NAMSA’s on-demand webinar, “The COVID-19 Pandemic: Proper Clinical Study Management & Protecting Data Validity.” https://t.co/SKGgqBOydk #medicaldevices #covid https://t.co/SCLXlllcug
The COVID-19 pandemic is threatening the validity of many #clinicalresearch programs that are currently underway. View NAMSA’s on-demand webinar, “The COVID-19 Pandemic: Proper Clinical Study Management & Protecting Data Validity.” https://t.co/SKGgqBOydk #medicaldevices #covid https://t.co/SCLXlllcug
Tuesday, April 7th, 2020 at 6:33am
Join NAMSA tomorrow for our webinar, “Optimizing Electronic Data Capture (EDC) System for IVD Clinical Trials,” to learn about key factors to consider while selecting an EDC platform and more! https://t.co/7tta4PxY8w #CRO #IVD #EDC #clinicalresearch #clinicaltrials https://t.co/qRtWRtqhAZ
Join NAMSA tomorrow for our webinar, “Optimizing Electronic Data Capture (EDC) System for IVD Clinical Trials,” to learn about key factors to consider while selecting an EDC platform and more! https://t.co/7tta4PxY8w #CRO #IVD #EDC #clinicalresearch #clinicaltrials https://t.co/qRtWRtqhAZ
Monday, April 6th, 2020 at 9:19am
This special-release episode of NAMSA's BiocompCHATibility podcast series explores the COVID-19 Pandemic and the production of ventilators and respirators to help treat and prevent spread of this virus. https://t.co/QBsDpSbLkD #medtech #medicaldevices #coronavirus #FDA https://t.co/gizdasNDwy
This special-release episode of NAMSA's BiocompCHATibility podcast series explores the COVID-19 Pandemic and the production of ventilators and respirators to help treat and prevent spread of this virus. https://t.co/QBsDpSbLkD #medtech #medicaldevices #coronavirus #FDA https://t.co/gizdasNDwy
Friday, April 3rd, 2020 at 12:14pm
On 3 April, the #EU Commission published a proposal to delay the date of application for certain MDR provisions by one year, to 26 May 2021. NAMSA’s regulatory experts have created a quick guide to help you understand the potential impact to business: https://t.co/p8gPV8mI65 https://t.co/aXBrzOCRea
On 3 April, the #EU Commission published a proposal to delay the date of application for certain MDR provisions by one year, to 26 May 2021. NAMSA’s regulatory experts have created a quick guide to help you understand the potential impact to business: https://t.co/p8gPV8mI65 https://t.co/aXBrzOCRea
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EU Parliament Votes to Institute the New IVDR and MDR Regulations; Transition Period Expected to Begin on June 1, 2017
The New EU Medical Devices Regulation (MDR) and In vitro Diagnostics Regulation (IVDR) were approved by the EU Parliament on April 5, 2017. The final regulations, expected to be published …
Updated German Legislation for Medical Devices
Following the EU regulation updates, the German legislator amended regulations relating to medical products to better align with the changing market. Existing databases were also updated so authorities and consumers …
CE Marking of Digital Health Technologies: Stricter Rules for Medical Device Software under the EU MDR
Introduction Increasingly, the world is engaged in conversations surrounding mobile and digital health applications. These types of platforms – broadly defined – encompass everything from pedometers, fitness apps, exercise diaries …