Custom-made medical devices and Regulation 2017/745
What are custom-made medical devices? A custom-made medical device is defined as follows: “any device specifically made in accordance with...
What are custom-made medical devices? A custom-made medical device is defined as follows: “any device specifically made in accordance with...
The requirements to obtain the conformity with Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) include something new compared...
Medical devices are a wide range of products used in the medical field for diagnostic or therapeutic purposes, including syringes...
Article 61 of the MDR defines the requirements to carry out a clinical evaluation of a medical device. Further clarifications...
Drug traceability is a relevant and delicate aspect of pharmaceutical management. In fact, it allows unique identification of every single...
On 3 January 2024, the Legislative Decree of the Ministry of Health no. 218 of 7 December 2023 was published...
On 8 January and 15 January 2024 the obligations on the traceability of some types of in vitro diagnostics and...
With the increasing requirements to obtain the MDR conformity, much more than for the MDD as well as the reduction...
In July 2023 the European Commission has published the first results of the survey carried out by Gesundheit Österreich GmbH...