Articles tagged with: Deadlines and exemptions

Class I devices without a UDI code on their label are no longer compliant with current regulations.

The NIS2 Directive imposes cybersecurity obligations on medical device manufacturers that are medium and large enterprises.

The Ministry of Health has defined mandatory actions for updating legacy device registrations in the database.

The recent extension of the MDR has raised several questions. This article provides answers to the most common ones.

The European Commission has accepted the proposed MDR extension. MDD certificates remain valid beyond their expiration date.

The European Commission is voting on a further postponement of MDR applicability to 2027/2028 for medical devices.

By April 30th of each year, it is mandatory to declare promotional activity expenses and pay the 5.5% contribution to the Ministry.

Regulation 2017/745 (MDR) defines the dates for compliance with the requirements for obtaining and applying the UDI code.

After the latest modification to the medical devices database, action is required to update existing registrations. The details.

While waiting for Eudamed, registration in the Ministry's database remains mandatory. This includes devices under MDR.