UK – MHRA releases spate of new guidelines on decentralized manufacturing
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released six guidelines to clarify expectations and support the new regulatory framework for...
Europe – MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for...
When a sponsor of a clinical investigation submits an application according to article 70(1) of the MDR, to the Member State(s) in which the...
UK – Medical devices: UK approved bodies
Approved bodies under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) for medical devices...
Europe – The European Medical Technology in Figures 2023
Capturing the activity of the medical technology industry is vital for healthcare stakeholders, business leaders and policymakers.
Updated regularly, this platform draws on data from...
Europe – The clock is ticking – MedTech Europe’s recommendations ahead of May 2025...
Class D IVDs are critical for public health. They mainly fall into two categories: a) those related to blood, cells, tissues or organ screening,...
UK – Decision tree for navigating nanotechnology-based products for medical application
The decision tree above is to help support researchers and developers to understand how different guidelines from the International Council for Harmonisation of Technical...
Europe – Nouveau Organisme notifié au titre du Règlement (UE) 2017/745
Nouveau Organisme notifié au titre du Règlement (UE) 2017/745
Europe – Ongoing consultations under the PECP
This page lists the views provided by the in vitro diagnostics expert panel under the Performance Evaluation Consultation Procedure (PECP) according to Article 48(6)...
Europe – Monitoring the Availability of Medical Devices and In Vitro Diagnostic Medical Devices...
Medical devices (MDs) and in vitro diagnostic medical devices (IVDs) are essential for a working healthcare system and play a crucial role in the...
UK – Medical devices: UK approved bodies
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)...
