and regulatory guidance tailored to each device’s unique requirements. Our expertise spans the entire lifecycle of medical devices, from design and development through to post-market surveillance, ensuring that all products, regardless of their type or complexity, meet the necessary regulatory standards...
Experts in Medical Device and Cosmetics Consultancy, UK Responsible Person & cosmetic regulations. Streamline your compliance with Advena.
Unique Device Identification (UDI) and device registration Notified Bodies and certificates Clinical investigations and performance studies Vigilance and post-market surveillance Market surveillance There is the EU guidance on practices in the transition to fully availability of EUDAMED for MDR and IVDR (MD...
PSUR), the contents and structure of which are explained in detail in the guideline "MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745". In addition to the summary
(UDI) and device registration 3 Notified Bodies and certificates 4 Clinical investigations and performance studies 5 Vigilance and post-market surveillance 6 Market surveillance There is the EU guidance on practices in the transition to fully availability of EUDAMED for MDR and IVDR (MDCG 2021-1, ...
PHAME’s range of medical device solutions helps support clients throughout the whole lifecycle, from development, to production, registration and distribution. Its services include: Guidance for medical device regulation (MDR) and in-vitro device regulation (IVDR) ...
For further guidance see MDCG 2020-13. EQUIVALENCE UNDER MDR The following technical, biological and clinical characteristics MUST be considered for the demonstration of equivalence (MDR Annex XIV part A 3): Technical: the device is of SIMILAR design, conditions of use, spec...
To be able to follow this strategy, these must fulfill the defined criteria in this guidance document to be considered a well-established technology (WET): If a manufacturer can successfully demonstrate to the Notified Body that a medical device can be considered a well-established technology, he...
A detailed review on the requirements of MDSAP participating countries in comparison with the European Medical Device Regulation 2017/745'. Disclaimer This guidance is commissioned text from expert authorities in their industry. It has been commissioned, edited and peer-reviewed before publicati...
Unique Device Identification (UDI) and device registration Notified Bodies and certificates Clinical investigations and performance studies Vigilance and post-market surveillance Market surveillance There is theEU guidanceon practices in the transition to fully availability of EUDAMED for MDR and IVDR (MDCG...