March sees the addition of a new notified body designated under the Regulation (EU) 2017/745 (MDR). The notified body is from Sweden and is listed below: This new addition brings the total number of notified bodies designated under the MDR to 44. More information regarding this new notified body can be found using the following … Read more
Earlier this month, our regulatory associate, Sam Attard, attended Medical Fair India in Mumbai on behalf of Advena. During this exhibition, Sam has met a number of existing clients as well as new potential clients that needed help with CE marking their medical devices. This is the first time Advena has visited an event in … Read more
LNE-GMED (8521) and Scarlet (8536) have just been given approved body status by the Medicines and Healthcare Products Regulatory Agency (MHRA). These new additions bring the total number of UK approved bodies to 9. The full scope of LNE-GMED can be accessed using the following link The full scope of Scarlet can be accessed using … Read more
As many of our readers are aware, earlier this month, Advena participated at Arab Health Medical Trade Fair. Arab Health is considered to be one of the biggest Medical Trade Shows in the Middle East and saw a total of 3,450 companies exhibiting and a further 110,000 visiting in this year’s edition of the trade … Read more
The MDCG has released a guidance document concerning EMDN codes. This document is split into three main sections and provides an overview of the actors involved in the generation and maintenance of the EMDN codes and lays out the procedures for the annual revision of the EMDN Codes as well as the procedure for ad-hoc … Read more
The first MDCG guidance document released for 2024 is concerning the vigilance systems for Specific CE-Marked devices. The aim of this guidance document is to harmonise vigilance reporting and provide guidance for manufacturers of Specific Devices. This document outlines the way to report incidents and serious incidents, in accordance with Articles 87 and 88 MDR … Read more
The introduction of the IVDR came with very substantial regulatory changes to the regulatory framework for IVD’s. One of the most significant changes is the increased involvement of independent notified bodies for the conformity assessment that is proportionate to the classification of the device. Under the IVDD, only a small number of high-risk devices equating … Read more
The EU commission is proposing making some of the EUDAMED modules mandatory at an earlier stage, by Quarter 4 of 2025. Under the current legislation, EUDAMED will become mandatory when all 6 modules are functional, which due to some delays in the development of the module for clinical investigations/performance studies, would be late 2029. Under … Read more
We are pleased to announce that we will be attending Medical Fair India as a visitor. The exhibition will be held on the 13th – 15th March at the Bombay Exhibition Centre in Mumbai. Medical Fair India is India’s no. 1 exhibition and conference for healthcare and with participation from over 20 countries, this fair … Read more
The EU is made up from 27 countries, most of them having their own national language. Since there is no official language of the European Union, each member state has different requirements that would need to be respected when making a device available in a particular member state. The MDR and IVDR both contain legal … Read more
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