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
Wednesday, June 12th, 2019 at 7:20am
Press Release: NAMSA recognized as a leading medical device CRO for third consecutive year by Life Science Leader; honored as a top performer in the categories of Capabilities, Compatibility and Quality. Read more: https://t.co/P4sNqfzPix #MRO #CRO #medtech #medicaldevice https://t.co/7OeXxnV119
Press Release: NAMSA recognized as a leading medical device CRO for third consecutive year by Life Science Leader; honored as a top performer in the categories of Capabilities, Compatibility and Quality. Read more: https://t.co/P4sNqfzPix #MRO #CRO #medtech #medicaldevice https://t.co/7OeXxnV119
Tuesday, June 11th, 2019 at 8:47am
Full house today at our #Biocompatibility and #Microbiology Training Series in Austin, TX! Were you unable to attend? No worries! We offer our Training Series throughout the year at different global locations. Learn more: https://t.co/ijOW4lmKY6 #medtech #medicaldevice #CRO #MRO https://t.co/cASSaV7G0r
Full house today at our #Biocompatibility and #Microbiology Training Series in Austin, TX! Were you unable to attend? No worries! We offer our Training Series throughout the year at different global locations. Learn more: https://t.co/ijOW4lmKY6 #medtech #medicaldevice #CRO #MRO https://t.co/cASSaV7G0r
Monday, June 10th, 2019 at 10:17am
In November 2018, CMDE developed draft guidelines regarding clinical trials performed on IVD reagents. Access NAMSA’s latest white paper to learn about these guidelines and how #IVD manufacturers can prepare for compliance. https://t.co/nWdOLi3eG8 #China https://t.co/QZ5k5kkN22
In November 2018, CMDE developed draft guidelines regarding clinical trials performed on IVD reagents. Access NAMSA’s latest white paper to learn about these guidelines and how #IVD manufacturers can prepare for compliance. https://t.co/nWdOLi3eG8 #China https://t.co/QZ5k5kkN22
Friday, June 7th, 2019 at 5:06am
Join NAMSA at MedFIT on 25 – 26 June. Stop by Booth #C2 and visit with NAMSA’s #medicaldevice development experts. To learn more, or to set up a complimentary consultation, visit: https://t.co/lfvxeM0BMR #medtech #MRO #CRO https://t.co/zkTDaEb82l
Join NAMSA at MedFIT on 25 – 26 June. Stop by Booth #C2 and visit with NAMSA’s #medicaldevice development experts. To learn more, or to set up a complimentary consultation, visit: https://t.co/lfvxeM0BMR #medtech #MRO #CRO https://t.co/zkTDaEb82l
Thursday, June 6th, 2019 at 5:35am
NAMSA invites you to meet with us at the upcoming EU #MDR and #IVDR MedTech Summit in Brussels, Belgium. NAMSA’s Clinical Study Manager, Deborah Klestadt, will present a session on 18 June regarding post-market clinical follow up. https://t.co/DlVwFXjKkX #medtech #clinical https://t.co/4RrmaPINdY
NAMSA invites you to meet with us at the upcoming EU #MDR and #IVDR MedTech Summit in Brussels, Belgium. NAMSA’s Clinical Study Manager, Deborah Klestadt, will present a session on 18 June regarding post-market clinical follow up. https://t.co/DlVwFXjKkX #medtech #clinical https://t.co/4RrmaPINdY
Wednesday, June 5th, 2019 at 8:54am
NAMSA invites you to read our latest blog post, “Three Essentials for Smart IVD Clinical Trial Design.” https://t.co/eX68RzruZh #medtech #biotech #CRO #MRO #medicaldevice #IVD #clinical https://t.co/YE0Y7WXZkZ
NAMSA invites you to read our latest blog post, “Three Essentials for Smart IVD Clinical Trial Design.” https://t.co/eX68RzruZh #medtech #biotech #CRO #MRO #medicaldevice #IVD #clinical https://t.co/YE0Y7WXZkZ
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 …