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IVDR (EU) 2017/746 Factsheet for Manufacturers of in vitro Diagnostic Medical Devices

The White Paper “Factsheet for Manufacturers of in vitro Diagnostic Medical Devices” explores the in vitro Diagnostic Medical Devices Regulation (IVDR) from the point of view of the Manufacturers. The document provides information on the obligations and requirements must be fulfilled in order to be ready on 26 May 2022, the date of full application [...]

2021-04-28T14:57:52+02:00April 28th, 2021|NEWSLETTER|

Medical Devices Labelling: instructions for use

The White Paper “Medical Devices Labelling: instructions for use” explains, from the regulatory point of view, what are the labelling requirements for Medical Devices according to the MDR (EU) 2017/745 Regulation. It is mandatory and fundamental to apply the requirements for the labelling of Medical Devices as the information on the product label helps the [...]

2021-04-26T13:58:15+02:00April 26th, 2021|NEWSLETTER|

Factsheet for Authorised Representatives, Importers and Distributors of Medical Devices and in vitro Diagnostic Medical Devices

By reading our  White Paper "Factsheet for Authorised Representatives, Importers and Distributors of Medical Devices and in vitro Diagnostic Medical Devices" you will get detailed information on: Economic Operators’ operating context;the regulatory changes introduced by the MDR (EU) 2017/745 and the IVDR (EU) 2017/746 ;new requirements related to Economic Operators. Download White Paper "Factsheet for Authorised [...]

2021-03-25T10:06:23+01:00March 25th, 2021|NEWSLETTER|
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