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 [...]
EU: Microplastics Reduction for Medical Devices
With the Regulation (EU) 2023/2055 of 25 September 2023 amending Annex XVII of Regulation (EC) No. 1907/2006, the European [...]
IMDRF: Published Guidance on Safety and Performance Principles for Medical Devices
On April 26, 2024, the International Medical Device Regulation Forum (IMDRF) published "Essential Principles of Safety and Performance of [...]
Thema CORP Joins LSPA and Philadelphia Chamber of Commerce
Thema CORP, the US-based Thema subsidiary, is pleased to announce its recent membership in the Philadelphia Chamber of Commerce and [...]
BRAZIL: B-GMP Extended to Four Years
On March 20, 2024, the Agência Nacional de Vigilância Sanitária (ANVISA) officially extended the validity of Brazilian Good Manufacturing [...]
EUROPE: Updated MDCG Guideline on Clinical Investigation Plan
In March, the Medical Device Coordination Group (MDCG) published the Guidance on the content of the Clinical Investigation Plan [...]
EUROPE: Deadline to Implement MDR Quality System and Application
On March 20, 2023, Regulation 2023/607 was published in the Official Journal of the European Union - EUR-Lex (Regulation [...]
AUSTRALIA: Updated Medical Device Labelling Requirements
On February 19, 2024, the Australian regulatory authority, Therapeutic Good Administration (TGA), updated the requirements regarding the labelling of [...]
CANADA: Increased Fees and Upcoming Deadlines for Medical Devices
April 1, 2024, represents a very significant date for the Medical Devices market in Canada. First, from this date, [...]
EUROPE: Harmonised Standards in the Medical Devices Industry
On March 6, 2024, the European Commission amended Implementing Decision (EU) 2021/1182 on harmonised standards for single-use medical gloves, [...]
EUROPE: Updated MDCG Guideline on Medical Device Nomenclature
Last February 2024, the Medical Device Coordination Group (MDCG) updated the MDCG 2024-2 Procedures for the updates of the European [...]
EUROPE: Proposed Extension for IVD Devices
On January 23, 2024, the European Commission proposed to extend the transition period provided for in Regulation (EU) 2017/746 for [...]
