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Dispositivi medici su misura

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...

person responsible for regulatory compliance

The person responsible for regulatory compliance (prrc)

The requirements to obtain the conformity with Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) include something new compared...

Feasibility study and gap analysis, two supporting tools for medical device manufacturers

Medical devices are a wide range of products used in the medical field for diagnostic or therapeutic purposes, including syringes...

PMCF

PMCF SURVEY – How to design a PMCF survey and obtain medical device clinical data

Article 61 of the MDR defines the requirements to carry out a clinical evaluation of a medical device. Further clarifications...

Tracciabilità del farmaco in Italia

Drug traceability, all subjects involved

Drug traceability is a relevant and delicate aspect of pharmaceutical management. In fact, it allows unique identification of every single...

Medicinali Veterinari

New developments for veterinary medicines

On 3 January 2024, the Legislative Decree of the Ministry of Health no. 218 of 7 December 2023 was published...

UDI tracking of medical devices and in vitro diagnostics: new rules in January 2024

On 8 January and 15 January 2024 the obligations on the traceability of some types of in vitro diagnostics and...

Are you really ready for the Regulation?

With the increasing requirements to obtain the MDR conformity, much more than for the MDD as well as the reduction...

Il tempo per gli MDR

Timetable for the compliance with the MDR/IVDR and Notified Bodies: where we stand

In July 2023 the European Commission has published the first results of the survey carried out by Gesundheit Österreich GmbH...