Shortages of Medical Devices: Questions and Answers on Article 10a of Regulation (EU) 2024/1860
22/11/2024 The European Commission has recently published a document entitled 'Q&A Obligation to inform in case of interruption or discontinuation [...]
Innovative Medical Devices in Saudi Arabia: Updated SFDA MDS – G002 Guidance. Version 3.0 (2024)
22/11/2024 In the wake of the increasing technological development in the medical device sector, the Saudi Food and Drug Authority [...]
MDCG Guideline 2022-5 Rev.1 Update: Clarification of Borderline Products between Medical Devices and Medicinal Products
22/11/2024 In October 2024, the Medical Device Coordination Group (MDCG) published the updated version of MDCG Guideline 2022-5 Rev. 1, [...]
Published MDCG Guidance 2024-11 for IVD Qualification
18/10/2024 On October 8, 2024, the Medical Device Coordination Group (MDCG) of the European Commission published the MDCG 2024-11 - [...]
ASCA Programme Updates: Three Draft FDA Guidelines
18/10/2024 On September 15, 2024, the FDA updated three draft guidelines related to ASCA (Basic Safety and Essential Performance), a [...]
CDRH Expands Voluntary Pilot Tap (Total Product Life Cycle Advisory Programme)
18/10/2024 On October 1, 2024, the FDA's Centre for Devices and Radiological Health (CDRH) in the US announced that devices [...]
Australia: Updated Checklist of Essential Principles for Medical Devices
In Australia, the Essential Principles represent a set of mandatory requirements designed to ensure that Medical Devices placed on the [...]
FDA: eSTAR Implementation Date Announced for de Novo Applications in Updated Guidance
The US Food and Drug Administration (FDA) recently announced in a guidance issued on August 23, 2024, entitled 'Electronic Submission [...]
Amendments to the Recall Regulation and MDEL in Canada: SOR 2024-136
On July 3, 2024, Regulation SOR 2024-136 was published in the Canada Gazette, an update that makes significant changes to [...]
FDA: Published Fees for Fiscal Year 2025
On July 31, 2024, the U.S. Food and Drug Administration (FDA) officially announced in the Federal Register the new medical [...]
EU: The Artificial Intelligence Act (AIA) included in the EU Official Journal
The European Commission has made available the final text of the Artificial Intelligence Act (AIA), the world's first comprehensive regulatory [...]
News for Economic Operators: Incident Guideline and Registration Form
As of June 3, 2024, the 'Guidance document Incident Economic Operators' is valid in Switzerland. This is a document [...]
MDCG 2021-5 Rev. 1: Updated ‘Guidance on Standardisation for Medical Devices’
On July 2, 2024, the Medical Device Coordination Group (MDCG) published the updated version of the 'Guidance on standardisation [...]
Regulation (EU) 2024/1860: Eudamed Plan Amendments And Legacy IVD Transitional Periods
On July 9, 2024, Regulation (EU) 2024/1860 of the European Parliament and of the Council amending the European Regulation [...]
MEXICO: First Authorisations of Innovative Software as a Medical Device (SaMD)
COFEPRIS, the Mexican regulatory authority, in May 2024 officially announced the approval of the first software as a SaMDmedical [...]
EMA: Updated Questions and Answers Guidelines on Devices Used in Combination with Medicines
In May 2024, the European Medicines Agency (EMA), together with the Coordination Group for Mutual Recognition and Decentralised Procedures [...]
BRASIL: Reliance Programme Accelerated Access for Medical Devices Already Registered in Other Countries
As of June 3, 2024, it will be possible to place one's high-risk Medical Devices in Brazil, relying on [...]
SWITZERLAND: Marketing and Legacy Devices
Taking a step back in time, it is recalled that Switzerland has been considered a Third Country for Europe [...]
