JD Supra

European Commission Proposes Amending Transitional Provisions in Medical Devices and In Vitro Diagnostics Regulations

On 6 January 2023, the European Commission adopted a proposal to amend the transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro ...
JD Supra

Medical Devices in the EU: MDD Certificates Remain Valid - the EU Extends Transition Periods for MDR Compliance, and Sell-Off Dates for Devices Under MDD and IVDD Fall Away!

Today, on Monday, March 20, 2023, Regulation (EU) 2023/607 of the European Parliament and of the Council of March 15, 2023, amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards transitional ...
Healio

FDA releases final rule on classification, reclassification of medical devices

Please provide your email address to receive an email when new articles are posted on . The FDA issued a final rule that implements modifications made by the FDA Safety and Innovation Act, as well as ...
Nasdaq

Wright Medical Group N.V. Announces Update to Medicare Transitional Device Pass-Through Payment for AUGMENT® Regenerative Solutions

AMSTERDAM, The Netherlands, July 20, 2020 (GLOBE NEWSWIRE) -- Wright Medical Group N.V. (NASDAQ: WMGI) today announced that the Centers for Medicare & Medicaid Services (CMS) published an update to ...
The Financial Express

Approvals for medical devices may ease with new classification

Experts said that there's a need to constantly update the list so that its purpose doesn't get defeated. (Image/Freepik) The Central Drugs Standard Control Organisation’s (CDSCO’s) draft rules for ...
MD&M East

Practical Considerations for Draft Transition Plans for Devices Under EUAs or COVID Enforcement Policies

On Jan. 31, 2020, the Department of Health and Human Services (HHS) declared a public health emergency (PHE) related to the global COVID-19 pandemic. The declaration of a PHE enabled FDA to issue a ...