Quality Control & Compliance
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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.
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.
Day 2: IMDRF Guidance Documents In The Works
Discussions during the second day of the 25th session of the International Medical Device Regulators Forum focused on the establishment of working groups to iron out a plethora of issues for international harmonization.
Global Regulators Home In On Regulatory Reliance, Propose Universal Framework
Regulatory reliance was the theme on Day one of the 25th Management Committee of the International Medical Device Regulators Forum in DC, with regulators from across the globe touching on the need for clarity, consistency, and trust among the world’s various regulatory bodies. The attendance for this year’s meeting was largest in the history, with some 1,200 guests representing more than 60 countries and 550 public and private sector organizations.
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.
Biden Administration Requests $7.13Bn FDA Budget For FY2025, Includes $3.3Bn In User Fees
The White House’s 1,298-page budget request published on 11 March includes around $2m more than the total for FY24, which Congress approved on 8 March and the president signed the next day. Of the FDA’s total FY2025 spending, $3.286bn would come from user fees.
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.
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.
Warning Letters And Close-Outs – January/February 2024
The US Food and Drug Administration has released three warning letters and two close-outs so far this year, with missives citing problems with premarket authorizations, quality systems compliance and reporting.
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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