Pharmacovigilance consists in a set of activities to identify, assess, understand and prevent adverse events or any other issue related...
On 9 February 2019 Directive 2011/62/EU of the European Parliament and of the Council amending Directive 2001/83/EC, on the Community...
In April 2022, the awaited guideline on borderline devices was published pursuant to Regulation 2017/745. The document MDCG 2022-5, “Guidance...
On 16 February 2023, the Ministry of Health has published the memorandum letter “Operating Procedures for the Application of Authorisation...
An essential aspect to reach the goals of Regulation EU 2017/745 on medical devices is the implementation of the European...
The reference regulations on medical devices and active implantable medical devices (MDs) establish that all manufacturers, or their authorised representatives,...
Law-Decree 11 January 2023 no. 4 was published in the Italian Official Journal no. 8. This provides for a time...
On 6 January 2023 the European Commission has adopted a proposal to change the provisions regarding the transitory period for...
We all know how it is important today to keep up with the times in either personal or working fields,...
