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
Thursday, April 18th, 2019 at 6:04am
NAMSA Training Series offers industry-leading educational programs that provide expertise and insight into critical #medicaldevice topics. Join us for our upcoming trainings (certifications available). Register today! https://t.co/aoNUUhWbCv #medtech #biologicalsafety #EU #MDR https://t.co/zdU6oSsGvl
NAMSA Training Series offers industry-leading educational programs that provide expertise and insight into critical #medicaldevice topics. Join us for our upcoming trainings (certifications available). Register today! https://t.co/aoNUUhWbCv #medtech #biologicalsafety #EU #MDR https://t.co/zdU6oSsGvl
Wednesday, April 17th, 2019 at 6:00am
NAMSA is partnering with MassMEDIC on April 30 for a special one-day event, “Biological Safety of Medical Devices: Updates and Challenges.” To learn more, or to register, visit: https://t.co/PFa3p3esvt Discount available for MassMEDIC members. #biologicalsafety #medtech #MDR https://t.co/20tALKqtvO
NAMSA is partnering with MassMEDIC on April 30 for a special one-day event, “Biological Safety of Medical Devices: Updates and Challenges.” To learn more, or to register, visit: https://t.co/PFa3p3esvt Discount available for MassMEDIC members. #biologicalsafety #medtech #MDR https://t.co/20tALKqtvO
Tuesday, April 16th, 2019 at 8:01am
How could your #medicaldevice organization further leverage OUS #clinical data to comply with the #FDA’s updated IDE and PMA submission regulations? Join NAMSA tomorrow (April 17) for our complimentary webinar. To register, visit: https://t.co/p0gWEQlKMG #medtech https://t.co/zKss8aOTB3
How could your #medicaldevice organization further leverage OUS #clinical data to comply with the #FDA’s updated IDE and PMA submission regulations? Join NAMSA tomorrow (April 17) for our complimentary webinar. To register, visit: https://t.co/p0gWEQlKMG #medtech https://t.co/zKss8aOTB3
Monday, April 15th, 2019 at 7:05am
With #IVDR mandatory compliance just nearly three years away, choosing the right-fit Notified Body for your #IVD product is crucial. Join NAMSA on April 30 for our webinar, “How to Select the Right EU Notified Body for IVDR Compliance.” https://t.co/apiz6B9Yw1 #EU https://t.co/7wsL1WNoUK
With #IVDR mandatory compliance just nearly three years away, choosing the right-fit Notified Body for your #IVD product is crucial. Join NAMSA on April 30 for our webinar, “How to Select the Right EU Notified Body for IVDR Compliance.” https://t.co/apiz6B9Yw1 #EU https://t.co/7wsL1WNoUK
Friday, April 12th, 2019 at 9:43am
Did you miss NAMSA at the MedTech Strategist Innovation Summit? Check out our other upcoming events: https://t.co/HWVpMFH3wp Our #medicaldevice development experts always welcome the opportunity to meet with you to discuss the most efficient pathways to market. https://t.co/WtRRvfLk8P
Did you miss NAMSA at the MedTech Strategist Innovation Summit? Check out our other upcoming events: https://t.co/HWVpMFH3wp Our #medicaldevice development experts always welcome the opportunity to meet with you to discuss the most efficient pathways to market. https://t.co/WtRRvfLk8P
Thursday, April 11th, 2019 at 8:42am
Join NAMSA at the Extractables and Leachables 2019 conference May 7-9, 2019. Joshua Young, PhD (Senior Study Director, NAMSA) will present a session on May 8 regarding solvent selection. Learn more: https://t.co/aMgOWZJLFb #medtech #medicaldevice #chemicalcharacterization https://t.co/r5kqWOMayL
Join NAMSA at the Extractables and Leachables 2019 conference May 7-9, 2019. Joshua Young, PhD (Senior Study Director, NAMSA) will present a session on May 8 regarding solvent selection. Learn more: https://t.co/aMgOWZJLFb #medtech #medicaldevice #chemicalcharacterization https://t.co/r5kqWOMayL
Trending Articles
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 …
MDR Transition Timelines for Legacy Medical Devices – Not without Risks and Undue Burden
The approval of the new European (EU) Medical Device Directive (MDR) and EU In Vitro Diagnostic Regulation (IVDR) on April 5, 2017 by the EU Parliament in Strasburg, France has …
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 …