News and Updates
CDSCO cosmetic product registration cancelled: what this case teaches manufacturers
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 [...]
Legacy devices: no need to update the label with a UDI-DI
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 [...]
PRRC MDR IVDR: role, requirements and compliance duties
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 [...]
What happens after May 26, 2025? UDI-DI compliance and market consequences
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 [...]
CE marking for Class I medical devices: Can I self-certify my product?
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 [...]
How to register a medical device or IVD in Saudi Arabia: SFDA registration process explained
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, [...]
New MIR 7.3.1 form mandatory from November 2025
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 [...]
How to obtain CE marking for medical devices in Europe: A complete guide for non-European manufacturers
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 [...]
DNV joins the IVDR framework as a Notified Body: A new option for IVD manufacturers
DNV designated as IVDR Notified Body The list of IVDR Notified Bodies continues to grow, and as of April 30, 2025, DNV Product Assurance, based in Norway, has officially joined the system. Added to the NANDO database under number NB [...]
