News and Updates

Creating technical documentation for MDR compliance can be challenging. Although many manufacturers believe they meet all the requirements, issues still arise during assessments. These issues often lead to delays or rejections. Therefore, understanding the most frequent mistakes is essential for [...]

On May 20, 2025, the Central Drugs Standard Control Organisation (CDSCO), India’s national authority for drugs and cosmetics, cancelled the registration of several imported cosmetic products. The decision followed the discovery of salicylic acid concentrations that exceeded the limits allowed [...]

If you are still placing legacy medical devices on the EU market, here’s a simple but important reminder: you do not need to update your labels to include a UDI-DI. What are legacy devices? Legacy devices are medical devices certified [...]

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. This [...]

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 all [...]

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 article, [...]

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 [...]