Noticias y novedades
How to write an EU Declaration of Conformity?
What is an EU Declaration of Conformity? An EU Declaration of Conformity (DoC) is a legal document in which the manufacturer states that their device complies with the applicable European regulations (MDR or IVDR). It must be signed by [...]
EU Health Technology Assessment: public consultation and Joint Scientific Consultations now open
The implementation of the EU Health Technology Assessment (HTA) Regulation has reached a crucial stage. In June 2025, the European Commission introduced two important initiatives. These developments directly affect developers of medical devices, in vitro diagnostic devices, and medicinal [...]
Sterile gloves, sterile devices and patient transport equipment: what changed in 2025
In 2025, the European Commission introduced a new set of harmonised standards under the MDR (EU) 2017/745 and IVDR (EU) 2017/746 frameworks. These updates directly affect MDR technical documentation required for compliance and market access. If you manufacture single-use [...]
6 common mistakes in MDR technical documentation (and how to avoid them)
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 [...]
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 [...]
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. [...]
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 [...]
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 [...]
