Articles & Video
The EU MDR Delay and Implementation - MedTech eBook Series
Discover the challenges of EU MDR implementation and impacts of the delay on the medical device industry in this MedTech eBook.
MedTech Report 2020: EU MDR and IVDR Compliance
Download the MedTech Report 2020 on EU MDR and IVDR Compliance, based on 265 survey responses from industry insiders.
EU Notified Body Association Takes Steps to Allay EC's Virtual Audit Fears
Amanda Maxwell looks at how the EU Notified Body Association is helping allay virtual audit fears.
MedTech Summit 2020 Post-Event Report
Find the latest on EU MDR, IVDR and medical device law in this MedTech Summit 2020 Post-Event Report.
Clinical Evaluations for Medical Devices and IVDs - MedTech eBook Series
Discover how the EU MDR will affect clinical evaluations for medical devices and IVDs in this MedTech Summit eBook.
Barriers and Challenges for Global Regulatory Harmonization
What obstacles are keeping regions such as Latin America from achieving regulatory harmonization with the rest of the world?
MedTech Digital Week 2020 agenda revealed
We reveal the full agenda of the 3-day webinar series providing EU MDR and IVDR updates and practical insights for implementation.
Update on the EU MDR delay and impact on industry - Panel discussion
With confirmation of the EU MDR delay due to COVID-19, MedTech Summit brought together four industry insiders to discuss the update and the impacts it will have on industry.
Article 117: Preparing Drug Device Combination Product Manufacturers for the EU MDR - WHITEPAPER
Article 117 EU MDR: This whitepaper offers advice to prepare drug device combination product manufacturers for the new regulations.
Preparing your organisation for MDSAP: Australia, Canada, Japan, Brazil - WHITEPAPER
This whitepaper details how your organisation can prepare for the Medical Device Single Audit Program (MDSAP) in Australia, Canada, Japan and Brazil.
Manufacturing Incident Reports (MIR) under the EU MDR - WHITEPAPER
This whitepaper explores Manufacturing Incident Reports (MIR) for medical devices under the EU MDR.
Regulatory challenges for Software as Medical Device (SaMD) and AI
We asked six medical device industry experts about the regulatory challenges of Software as Medical Device (SaMD) and Artificial Intelligence.
EU MDR: Assessing the impact on biocompatibility testing
This whitepaper examines the regulatory changes brought by the EU MDR around medical device biocompatibility testing, and how compliance will affect common practice.
MedTech TV: EU MDR and IVDR implementation challenges
At MedTech Summit in Brussels we interviewed two industry insiders on the hottest topics facing the industry for MedTech TV - watch the full interviews here.
EU MDR: New expectations for clinical evaluations and investigations - WHITEPAPER
In May 2020 the EU MDR officially replaces the EU MDD. This whitepaper assesses new expectations for clinical evaluations and investigations under the EU MDR.
Understanding how ISO 10993-17 and ISO 10993-18 connect - WHITEPAPER
This whitepaper explores parts 17 and 18 of ISO 10993, how they relate, and considerations for industry.
Comparing EU and FDA approaches to regulating MedTech software and AI - WHITEPAPER
This whitepaper explores the different EU and FDA approaches to regulating MedTech software and AI.
Regulatory development opportunities for global harmonisation of eSubmissions
What's delaying the global harmonisation of eSubmissions for market authorisation? This whitepaper examines the latest developments and ongoing challenges.
MedTech 2020 Survey: EU MDR and IVDR Compliance
Complete our MedTech survey on EU MDR and IVDR Compliance to be in with a chance of winning a 2 day conference pass to MedTech Summit.