Singapore – Singapore adds HIBCC to list of UDI issuing agents
Singapore’s medical device market regulator, the Health Sciences Authority (HSA), has announced that a new designated issuing agency (IA) has been added to its...
USA – MedCon: Consider the device risk management file a ‘living document’
Device manufacturers need to keep their risk documentation up to date throughout the total product life cycle by monitoring production and post-production information, according...
Europe – Update – MDCG 2022-13 Rev.1 – Designation, re-assessment and notification of conformity...
This document aims to provide guidance to the authorities responsible for notified
bodies (hereafter, the Designating Authorities) and joint assessment teams (JATs)
when conducting:
− assessments of...
USA – FDA updates off-the-shelf software guidance to reflect least burdensome approach
The US Food and Drug Administration (FDA) has reissued a final guidance on off-the-shelf (OTS) software used by medical devices, which aims to reduce...
International – Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device...
Standards perform a key role in the conformity assessment process; however, utilizing
existing standards for recognition of medical device CABs performing regulatory
reviews presents challenges. Regulatory...
Europe – Stakeholders seek short-term fixes, long-term reform for European medtech regulations
Medtech stakeholders say there needs to be a reform of the European medtech regulatory system to improve efficiency, consistency and agility.
Cracks in the current...
Spain – AEMPS-affiliated notified body becomes first Spanish group designated under MDR
A notified body associated with the Agency of Medicines and Medical Products (AEMPS) has become the first Spanish group designated to assess products under...
Europe – MDR transition delay needs clarification, industry engagement to succeed
Whether the new proposal from the European Commission to delay the EU Medical Device Regulation (MDR) transition period works out will depend on the...
UK – MHRA announces a proposed framework for international recognition of medical devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (21 May 2024) published a statement of policy intent for international recognition of medical devices.
The MHRA’s...
Europe – Questions and Answers: Commission proposes an extension of the transitional periods for...
The EU rules on the safety and performance of medical devices were created in the 1990s. In April 2017, the European Parliament and the...
