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 [...]
22 10 2020
22 10 2020
22 09 2020
22 09 2020
EU: published guidance for Instructions For Use (IFU) for reusable devices
At the end of July 2020 the European Commission published a guide to address the issue of frequent non-compliance with instructions [...]
22 09 2020
22 09 2020
SWITZERLAND: harmonization of the regulatory system to MDR is underway
Last July 2020 the Swiss Federal Council approved the revision of the Medical Devices Ordinance (MedDO), along with the new Ordinance [...]
22 09 2020
22 09 2020
EU: MDCG published updated guidelines and new MDSAP audit
The Medical Device Coordination Group (MDCG) has recently published some updated guidelines as support for the implementation of the new Medical [...]
08 09 2020
08 09 2020
In Vitro Diagnostic Medical Devices Regulation IVDR (EU) 2017/746: main changes
The Regulation on In Vitro Diagnostic Medical Devices IVDR (EU) 2017/746, published on May 5, 2017 and entered into force on [...]
20 08 2020
20 08 2020
Transitional period: can in vitro Diagnostic Medical Devices, conform to the current IVDD, be placed on the EU market after May 26, 2022?
The European Parliament, by publishing the EU 2022/112 Regulatory, modified the transitional periods, initially foreseen by IVDR art. 110, as following: [...]
20 08 2020
20 08 2020
What is the “sell off” provision?
The goal of the “Sell Off” provision (IVDR art. 110 para 4) is to reduce the amount of time in which [...]
20 08 2020
20 08 2020
Is it possible to self-certificate devices in the field of the Regulation on in Vitro Diagnostic Medical Devices IVDR (EU) 2017/746?
In most cases, Class A devices can be self-certified, unless they are sold sterile, while for Class B, C and D [...]
20 08 2020
20 08 2020
What are the main changes provided for in the Regulation on in Vitro Diagnostic Medical Devices IVDR (EU) 2017/746?
Manufacturers of in vitro diagnostic Medical Devices must face important news provided for in the Regulation on in Vitro Diagnostic Medical [...]
20 08 2020
20 08 2020
How does the Regulation on in Vitro Diagnostic Medical Devices (IVDR) affect the Quality Management System?
When the transitional period will end, all the IVDs to market in the European Union will have to satisfy the requirements [...]
