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+++ Latest NEWS: Getting ready for the upcoming regulations +++ Latest DOCUMENTS added to our Library of Documents - EC List of Expert Panels +++ MDR Regulatory Strategy: implementation guide in STORE now +++ WEBINAR on PRRC & Quality Agreements with your distributors +++ Our memberships give access to our comprehensive Library of documents, News section, regulatory alerts,...

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Dedicated webpages on MDR & IVDR (European Commission)

The European Commission has released dedicated webpages, which are divided in several areas, where you…

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New MDR NB & UK MHRA Guidance & QMS Remote Audits

SGS FIMKO OY has joined the list of certification bodies notified under the Regulation (EU)…

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MDR & IVDR: How many NBs we have?

The end of Brexit transition period (31/12/2020) has brought many important changes also for the…

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Update: EC Implementing acts and MDCG Guidance in 2020 & 2021

With the release of the latest Implementation Rolling Plan, we present below future implementing acts/actions…

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UDI assignment for Spectacle lenses & Ready readers

The MDR is introducing the obligation of manufactures to assign the Unique Device Identification (UDI)…

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MDR: 18th Notified Body on NANDO!

The NANDO database newly lists 18 Notified Bodies under the MDR! UDEM Adriatic is the…

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COVID-19 & NB audits: MDCG Q&A

The MDCG issued a Questions & Answers (Q&A) document concerning the previously issued Guidance on temporary…

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Actor registration to EUDAMED is now possible!

Actor module of EUDAMED is active as of December 1, 2020! It is now possible…

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IVDR: 5th Notified Body on NANDO!

The NANDO database is richer for a new Notified Body under the IVDR! TÜV Rheinland…

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EUDAMED Actor Registration: European Commission Q&A

Actor Registration to EUDAMED shall be available from next Tuesday (1.12.2020), as communicated earlier on…

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IVDR: MDCG Guidance on Classification Rules for in vitro diagnostic medical devices released!

The MDCG published a very important document for all IVD manufacturers, as well as for…

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Building a European Health Union: medical device shortage addressed

The European Commission presented its new Communication Building a European Health Union: Stronger crisis preparedness…

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