5 Deficiencies actually received during compliance to MDR (EU) 2017/745
In this Whitepaper you will find the answers to some of the most common Deficiencies issued during MDR (EU) 2017/745 [...]
11 11 2022
11 11 2022
26 09 2022
26 09 2022
Regulatory Affairs – Minimum requirements, skills and role of a growing profession
The Regulatory Affairs Professional in the medical field plays a significant and decisive role throughout the device’s lifecycle. In this [...]
23 06 2022
23 06 2022
Exporting Medical Devices in Europe? You need a European Authorised Representative
This White Paper focuses on the figure of the European Authorised Representative (EU REP), who plays a fundamental role in the [...]
21 09 2021
21 09 2021
UK: postponed the mandatory UKCA marking. What happens now with Medical Devices and IVDs?
On August 24th ,2021, the UK government decided that mandatory UK Conformity Assessed (UKCA) marking would be delayed to January 1st [...]
31 05 2021
31 05 2021
MDR: Switzerland becomes a Third Country in the Medical Device Sector
UPDATE 31/05/2021 Since 26 May 2021, with the full application of the Medical Device Regulation MDR (EU) 2017/745 and in the [...]
28 04 2021
28 04 2021
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) [...]
23 04 2021
23 04 2021
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 [...]
22 10 2020
22 10 2020
UK: BREXIT, what changes from 1 January 2021
On September 1, 2020 the Medicines and Healthcare products Regulatory Agency (MHRA) published new rules to be respected for placing and [...]
20 05 2020
20 05 2020
MDR & IVDR Rolling Plan Infographic
The following infographic highlights, in chronological order, the scheduled deadlines and the progress of the work with regard to the implementing [...]
27 04 2020
27 04 2020
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" [...]
