The EU Commission has released draft documents correcting aspects of the Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746. These drafts are currently under review by …
Recent Articles
EMA Issues Q&A Regarding Impact of MDR, Article 117
Often overlooked, Article II7 of the European Union’s (EU) Medical Device Regulation (MDR 2017/745) lurks within Chapter X of the Final Provisions. However, this article is of high impact to …
EU Issues Q&A Document to Provide Further Analysis of Potential No-Deal Brexit
Twelve (12) months ago, the EU Commission published a Notice to Stakeholders, “Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products,” that described the consequences …
UK MHRA Releases Contingency Legislation Covering Regulation of Medical Devices in Brexit ‘No Deal’ Scenario
On the 24 January 2019, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) published contingency legislation which provides regulatory guidance for medicines, medical devices and clinical trials in the …
EU Commission Updates Website to Provide Additional MDR and IVDR Planning Resources
The EU Commission’s website dedicated to Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) planning has recently been updated, and now includes a new and dedicated page for …
Social Media
Friday, August 16th, 2019 at 11:05am
Join NAMSA at the upcoming Medical Alley Innovation Summit in Minneapolis in September! Our medical device development experts will also be available throughout the summit for complimentary consultations. https://t.co/BGW25LT2aK #medtech #medicaldevice #CRO #MRO https://t.co/rd1fytYGOY
Join NAMSA at the upcoming Medical Alley Innovation Summit in Minneapolis in September! Our medical device development experts will also be available throughout the summit for complimentary consultations. https://t.co/BGW25LT2aK #medtech #medicaldevice #CRO #MRO https://t.co/rd1fytYGOY
Thursday, August 15th, 2019 at 11:00am
Join NAMSA on September 4 for the webinar, “Impacts of the Updated ISO 14971 & Harmonization of MDR/FDA Rules on Risk Management,” presented by Linda Mummah-Schendel and Rich Granquist. Register today: https://t.co/cSWuYtsdhG #medtech #medicaldevice #regulatory #CRO #FDA #MDR https://t.co/m95vV6Yzrr
Join NAMSA on September 4 for the webinar, “Impacts of the Updated ISO 14971 & Harmonization of MDR/FDA Rules on Risk Management,” presented by Linda Mummah-Schendel and Rich Granquist. Register today: https://t.co/cSWuYtsdhG #medtech #medicaldevice #regulatory #CRO #FDA #MDR https://t.co/m95vV6Yzrr
Thursday, August 15th, 2019 at 6:01am
Join NAMSA’s regulatory experts, as well as Erica Conway from BSI, to learn suggested strategies and best practices to efficiently navigate the UK’s unique medical device development landscape. https://t.co/NmJ7rgqxB5 #IVDR #IVD #Brexit #CRO https://t.co/M8MiEYbzRV
Join NAMSA’s regulatory experts, as well as Erica Conway from BSI, to learn suggested strategies and best practices to efficiently navigate the UK’s unique medical device development landscape. https://t.co/NmJ7rgqxB5 #IVDR #IVD #Brexit #CRO https://t.co/M8MiEYbzRV
Wednesday, August 14th, 2019 at 9:39am
Access NAMSA's latest white paper, “Medical Device Biological Evaluation Reports: Relevance to the Revised ISO 10993-Part 1: 2018,” to better understand how to properly address the updated requirements within evaluation reports. https://t.co/0WLAXxH6co #biologicalsafety #medtech https://t.co/PsrJgFrD7K
Access NAMSA's latest white paper, “Medical Device Biological Evaluation Reports: Relevance to the Revised ISO 10993-Part 1: 2018,” to better understand how to properly address the updated requirements within evaluation reports. https://t.co/0WLAXxH6co #biologicalsafety #medtech https://t.co/PsrJgFrD7K
Wednesday, August 7th, 2019 at 8:31am
NAMSA’s highly sought-after educational programs provide insight into critical medical device development topics. Led by our CRO development experts, courses are interactive to promote engagement between attendees and industry thought leaders. Learn more: https://t.co/yQ3XFGbJj1 https://t.co/JColD9vvHA
NAMSA’s highly sought-after educational programs provide insight into critical medical device development topics. Led by our CRO development experts, courses are interactive to promote engagement between attendees and industry thought leaders. Learn more: https://t.co/yQ3XFGbJj1 https://t.co/JColD9vvHA
Monday, August 5th, 2019 at 9:47am
Unlike other industry events focused on #MDR, this hands-on training will be led by Notified Body expert, Adrian Keene (former Head of SGS and Technical Manager at LRQA). Sort through MDR regulatory components to understand what is really required: https://t.co/PKnqA9gaI5 https://t.co/dvmwzOduBB
Unlike other industry events focused on #MDR, this hands-on training will be led by Notified Body expert, Adrian Keene (former Head of SGS and Technical Manager at LRQA). Sort through MDR regulatory components to understand what is really required: https://t.co/PKnqA9gaI5 https://t.co/dvmwzOduBB
Trending Articles
Unannounced Notified Body Audit
On 24th September 2013, the European Commission published a Recommendation (2013/473/EU) regarding assessments and audits to be performed by Notified Bodies in the field of medical devices. The goal of …
EU Commission Issues “Notice to Stakeholders: Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products”
On 10 January 2018, the EU Commission issued the document, “Notice to Stakeholders: Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products.” While this notice …
The Need for an Authorized Representative for Clinical Trials in the EU
Our previous email and blog post discussed the importance of preclinical studies to clinical trials. A vital step in the “benchtop to bedside” process model is the move from research …