Sistemir.com

Importing medical devices for COVID-19

WebThere are many companies struggling with the import of medical devices from non-EU countries – China in particular – to deal with the COVID-19 emergency. Here are …

Actived: 8 days ago

URL: https://sistemir.com/en/blog/importing-medical-devices-for-covid-19/

How to obtain the CE marking of medical devices

WebA product considered to be a medical device must be CE marked in order for it to be sold in Europe.. This is not a choice: the concept of “medical device” depends on …

Category: Medical Go Health

All about Eudamed, the European database of medical devices

WebEudamed is the information system developed by the European Commission to implement Regulation (EU) 2017/745 regarding medical devices. The aim is to provide …

Category: Medical Go Health

Vigilance of medical devices, the Ministry’s guidelines

WebEudamed plays a central role in the vigilance system envisaged by the Regulation. Most of the articles in relation to the topic (87, 88, part of 89 and 90), will not …

Category: Health Go Health

Advertising of medical devices, only if authorised

WebRegardless of the format chosen – press, social network, website, radio or short film – advertising of medical devices aimed at the public must be authorised by the …

Category: Medical Go Health

MDCG 2022-08: treating a self-inflicted injury

WebThe guideline MDCG 2022-08, issued in August 2022, raised an alarm about the possibility of shortages of medical devices due to the complexity of implementing the …

Category: Medical Go Health

Medical devices news

WebThis article defines the key aspects to produce, import, distribute or purchase protective masks during the COVID-19 emergency. Technically speaking, these are protective half …

Category: Health Go Health

Registering medical devices on the Ministry’s database

WebSince 1993, every nation in the European Community has been required to have its own system for registering medical devices.The aim is to provide manufacturers …

Category: Medical Go Health

Action required in the Ministry database

WebIn December 2021, the database of the Ministry of Health was modified to allow the inclusion of all information, certificates and documentation relating to devices …

Category: Health Go Health

Register UDI codes in Eudamed

WebFollowing the latest update of Eudamed it is possible to register UDI codes.The products to which the relative codes refer are: CE-marked medical devices …

Category: Medical Go Health

The dates of affixing the UDI code for medical devices

WebVAT n. 03924150133 Administrative index no. LC-407096 Share capital € 10,000.00 fully paid

Category: Health Go Health

MDR: the list of (few) harmonised standards

WebThe starting point for selecting the standards to be applied to a product is the analysis of the OJEU, the Official Journal of the European Union.. Within the framework …

Category: Health Go Health

Eudamed: the Commission publishes the official link

WebThe creation of a European database of medical devices is essential to achieve the objectives of the new regulation 2017/745.. Eudamed will improve the …

Category: Medical Go Health

The CND, when Italy is top of the class in Europe

WebFrom somewhat loud and passionate to now timid and wearing glasses with thick lenses, Italy was the first to raise its hand. And its answer surprised everyone.. In …

Category: Health Go Health

COVID-19 masks: rules for producing or importing

WebThis article defines the key aspects to produce, import, distribute or purchase protective masks during the COVID-19 emergency. Technically speaking, these are …

Category: Health Go Health

MDR a pieno regime, la classifica dei problemi meno noti

WebQuesto resoconto si focalizza sugli aspetti meno evidenti emersi durante le certificazioni MDR gestite finora e per i quali sono state necessarie soluzioni mirate al …

Category: Health Go Health

MDR: l'elenco delle (poche) norme armonizzate

WebIl punto di partenza per la scelta delle norme da applicare ad un prodotto, è l’analisi dell’OJEU, la Gazzetta Ufficiale dell’Unione Europea.. Nell’ambito della Direttiva …

Category: Health Go Health