Noticias y novedades

What is the role of the PRRC? The person responsible for regulatory compliance (PRRC) plays a key role in ensuring continuous compliance with EU MDR (2017/745) and IVDR (2017/746) throughout the lifecycle of medical and in vitro diagnostic devices. [...]

As of May 26, 2025, manufacturers of: class I medical devices (under MDR) class B and C in vitro diagnostic devices (under IVDR) will be allowed to place or keep products on the EU market only if they meet [...]

Many manufacturers assume that Class I medical devices can always be self-certified without the involvement of a Notified Body. But is that really the case? In this article, we clarify the distinctions within Class I devices and help you [...]

Getting started with SFDA registration If you plan to market a medical device or in vitro diagnostic (IVD) in Saudi Arabia, you must comply with the regulatory process established by the Saudi Food and Drug Authority (SFDA). In this [...]

The European Commission has released the new Manufacturer Incident Report (MIR 7.3.1) form. This updated MIR PDF format will become mandatory as of November 2025 for all manufacturers of medical devices under Regulation (EU) 2017/745 (MDR). Password-protected PDF form [...]

If you are a medical device or IVD manufacturer based outside the European Union and planning to sell your products in Europe, CE Marking is a legal requirement. This guide outlines the key steps to ensure compliance with the European [...]

Switzerland is preparing to introduce a more flexible regulatory framework to strengthen the supply of medical devices in its market. The Federal Council intends to establish a legal basis for granting market access, under justified conditions, to devices that do [...]

A new designation strengthening EU capacity for IVDR conformity assessments On April 23, 2025, the European Commission officially designated SGS Belgium NV as a Notified Body (NB 1639) under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). This [...]