Policy & Regulation
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Optimizing EU Medtech Regulatory Governance And Innovation: First Workshop Shapes Future Study
Work related to the European Commission’s promise to assess the impact of the Medical Device Regulation, including its impact on innovation, is starting to take shape.
New FDA Documents On Weight-Loss Devices, Software And International Harmonization As End Of Fiscal Year Nears
With the end of fiscal 2023 just over a week away, the US Food and Drug Administration has been publishing promised guidance documents, action plans and white papers. Medtech Insight’s round-up of four device-specific documents is below.
Representatives Press CMS On Coverage Of Innovative Devices
Medicare coverage of innovative and life-saving devices, drugs and diagnostics were the focus of a 19 September Congressional hearing during which representatives pressed for swifter and more predictable paths to reimbursement.
Exciting New Opportunities Launched In UK For Innovative Products As IDAP Gets Underway
Medtech developers have just over a month to apply for the pilot phase of a program offering regulatory and practical support to accelerate innovative product access to the UK NHS.
Optimizing EU Medtech Regulatory Governance And Innovation: First Workshop Shapes Future Study
Work related to the European Commission’s promise to assess the impact of the Medical Device Regulation, including its impact on innovation, is starting to take shape.
Exciting New Opportunities Launched In UK For Innovative Products As IDAP Gets Underway
Medtech developers have just over a month to apply for the pilot phase of a program offering regulatory and practical support to accelerate innovative product access to the UK NHS.
Entire EU Medtech Industry Throws Weight Behind Argument To Structurally Reform MDR And IVDR
The European Commission has conceded to the medtech industry’s calls to delay and modify the new EU regulatory requirements multiple times over the last few years. But will it yield to fresh calls for radical changes being sought by the most powerful lobby yet?
Finland’s Eurofins Becomes EU’s 11th Notified Body Designated Under the IVDR
The number of notified bodies designated under the IVD Regulation has now crept up to 11 as the first Finnish designation is announced.
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Article
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.