Archive

Articles tagged with: Surveillance and vigilance

Post-market Surveillance: PSUR in Two Steps

We share the high-level scheme applied to our clients: the most straightforward approach to post-market surveillance.

Matteo Valtorta

Manufacturers' duties Surveillance and vigilance Technical guide

Medical Device Vigilance: Ministry Guidelines

A new circular from the Ministry defines the methods for medical device vigilance while waiting for Eudamed to become operational.

Matteo Valtorta

Ministry of Health Surveillance and vigilance

Sufficient Financial Coverage, Mandatory for Manufacturers

According to Article 10 of the MDR, manufacturers must compensate for damages from defective products and have sufficient financial coverage.

Matteo Valtorta

Manufacturers' duties Surveillance and vigilance

The Medical Device Regulation (MDR) in General

The Medical Device Regulation (MDR) establishes the new European rules for conformity assessment. The key steps.

Matteo Valtorta

Deadlines and exemptions Surveillance and vigilance

Importing Medical Devices for COVID-19

Aspects to consider when importing medical devices from non-EU countries for the COVID-19 emergency.

Matteo Valtorta

Importers and distributors Surveillance and vigilance