Guidance on the vigilance system for CE-marked devices and the Device Specific Vigilance Guidance (DSVG) Template
This newsletter is aimed toward introducing the Device Specific Vigilance Guidance (DSVG), a pivotal document aimed at harmonsing vigilance reporting and offering comprehensive gui
Highlights from the 24th Management Committee Meeting of the International Medical Device Regulators Forum (IMDRF) in Berlin, Germany
In September 2023, Berlin hosted the 24th IMDRF Management Committee meeting, chaired by the EU and attended by over 550 global participants over five days, revealing significant d
Medical Device Regulation (MDR) European Union (EU) 2017/745 Transition – What is required by the May 2020 deadline?
Some manufacturers who have existing medical device MDD certificates may not transition before May 2020 and retain their current MDR until expiry, however a significant change to t
Overview of the role of Key Stakeholders in the Medical Device Regulations
The new MDR will apply across EU Member States from May 2020, under this regulation there are defined obligations which lie with the major stakeholders in the device lifecycle. The
Why is it so important to review and update your regulatory strategy?
Formulating a well defined and researched regulatory strategy is vital for medical device and in-vitro diagnostic (IVD) companies. The regulatory world is constantly evolving, with
The CE Mark matters in Medical Markets
Selling any product into the European market can be simplified if a manufacturer can show that it complies with appropriate regulations. For medical device manufacturers, this comp
EU New Medical Device Regulation 2016
As of 1 July 2024, new regulatory requirements for medical devices containing medicinal substances, or materials derived from animal, microbial, or recombinant sources will take ef
