Europe
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EU Institutions Reach Provisional Agreement On Proposed Health Data Regulation Amendments
Key changes have been agreed to the original European Commission text which would allow patients to opt out or restrict sharing of their information.
MedTech Europe Calls For Swift Answers In Areas Where AI Act Threatens MedTech
With the EU AI Act close to being finally adopted, industry is now calling for guidance and clarification to prevent the new legal text complicating the regulation of medical devices and diagnostics and putting obstacles in the way of patient access to innovation.
European Parliament Adopts AI Act, But Success Hangs On The AI Office
The European Parliament adopted the EU AI Act in plenary on 13 March. Experts say the wider success of the EU’s approach to AI is now in the hands of the EU AI Office.
40% Plus Growth In Notified Body Certificates Issued Under EU Medtech Regulations
After years of concern over notified body ability manage the volume of conformity assessment applications from medtech manufacturers, there is evidence that capacity has increased significantly, and this is showing results.
Unfair Bias In Device Design: UK MHRA And Government Promise Action
A 15-month UK independent review of ethnic and other biases in device design has called for treatment inequity to be addressed at the highest levels of government, more resources for the MHRA and equity assessments to be included in approvals and post market surveillance.
Harmonized Standards Under Medical Device and IVD Regulations Trickle Through
Two new sets of standards have been officially recognized under the MDR and one under the IVDR. But progress is slow, and the numbers of standards updated remains exceptionally low nearly seven years after the regulations were adopted.
US Group Supports EU Industry Concerns Over Revised Liability Laws
US industry, well acquainted with how damaging a litigious culture can be, warns EU over the impact of its Product Liability Directive on medtech and other sectors.
US Chamber Of Commerce Announces 5-Year Mission To Address Fundamental EU Problems
The European Commission can expect the US industry to be an active partner when it takes stock of its medtech regulations, given AmCham EU’s latest mission and vision for the EU.
New Swedish Notified Body Designated Under The EU's Medical Device Regulation
A newcomer has become the second notified body designated in Sweden under the MDR
Great News For Medtech Industry: European Harmonized Standards To Be Free-Of-Charge
The costs of purchasing European standards and their updates have been borne by manufacturers for many decades, irrespective of their size or turnover. Now that will change.
EU Batteries Regulation: Who Is Exempt And Why New Rules Could Force Product Redesign
There are significant differences in how medtech manufacturers and other economic operators are impacted by the EU’s new Batteries Regulation compared with the former Batteries Directive.
Interoperable Europe Act Promises Digital Cooperation Between Member States
The Council of the EU has adopted the Interoperable Europe act for more efficient digital public services across the EU. The act will apply to European common data spaces, including the European Health Data Space.
EHDS Regulation Needs To ‘Better Serve’ Its Intended Purpose
Trade association COCIR has released a list of five key recommendations that it says will “provide legal clarity” around the implementation of the EU European Health Data Space Regulation.
EU Regulatory Roundup February 2024: Progress, Trepidation And Promises
Good news in February for market transparency and for more time for the regulation of IVDs. But medtech is watching the likely impact of the AI Act and Batteries Regulation with apprehension.
German Row Over Classification Of Telemonitoring Software Looks Set To Rumble On
When does an app qualify as a medical device and when does it not? A German court case appears to have wider-reaching implications for medtech than might first appear.
AI Clinical Summarization Tools Sit In 'Regulatory Grey Area', Experts Warn
The EU lacks concrete guidance on whether clinical summarization large language models are considered medical devices. Experts push for EU adoption of the FDA “non-device” category.
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