News and Updates
New EU regulation on e-IFU: what changes for medical devices?
On 25 June 2025, the European Commission published a new regulation that allows all medical devices used by healthcare professionals in the EU to be accompanied by instructions for use (IFU) in electronic format. This update expands the use [...]
When does the AI Act apply to medical device software?
The AI Act applies to software intended to fulfil a medical purpose, when it qualifies as an AI system and is part of a medical device or IVD subject to MDR or IVDR. Only those requiring a conformity assessment involving [...]
Medical device software apps: what are the EU compliance requirements?
To legally publish a medical device software (MDSW) app in the EU, manufacturers must ensure full compliance with the MDR or IVDR before making the app available on a platform. This includes providing mandatory product information and aligning with [...]
What are the new Post-Market Surveillance requirements in the uk from june 2025?
Starting 16 June 2025, new post-market surveillance (PMS) obligations will apply to all medical devices placed on the market in Great Britain. These changes affect in vitro diagnostic (IVD) devices, implantables, and all classes of general medical devices. Manufacturers, authorised [...]
What is the EMDN and why does it matter for your medical device?
The EMDN code for medical devices is the official classification system adopted in the EU. It plays a key role in regulatory processes. As a result, it will be essential for registering products in EUDAMED once the database is fully [...]
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 a [...]
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 medical [...]
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 for [...]
