IVDR | Advena Ltd

UPDATE: MDCG 2020-16 rev.5: Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

25 September 2026 by Sam Attard

The Medical Device Coordination Group (MDCG) has updated its guidance on the classification of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR). The guidance provides clarification on the application of the classification rules set out in Annex VIII of the IVDR and is intended to support the consistent classification of IVDs across … Read more

26th September 2026 Deadline for Class C IVD Manufacturers

25 September 2026 by Sam Attard

For manufacturers of Class C In Vitro Diagnostic (IVD) medical devices, September 26, 2026, is a critical regulatory milestone. Under the EU In Vitro Diagnostic Regulation (IVDR), manufacturers of legacy Class C devices must have a signed written agreement in place with an EU Notified Body by this exact date to maintain European market access.

TEAM NB Release Template for the Agreement Related to the Transfer of IVDR Formal Application and of Appropriate Surveillance of Legacy Devices

26 June 2026 by Sam Attard

Team-NB members adopted, a template Agreement form related to the transfer of IVDR formal application and of appropriate surveillance of legacy devices specifying the terms of the transfer in respect of legacy devices covered by Directives certificates. The full template can be accessed using the following link

TEAM NB Publish Position Paper on Demonstration of Safety and Performance for Combinatorial Use of Reagent Devices with other devices or Equipment

5 March 2026 by Sam Attard

Team-NB has published a new guidance document outlining harmonised Notified Body expectations for demonstrating the safety and performance of reagent devices intended for use in combination with other devices, equipment, or instruments. The document clarifies key considerations for ensuring compliance with Regulation (EU) 2017/746 (IVDR). It is intended to support and complement the existing Team-NB … Read more

Update to IVD Classification Guidance to Strengthen Clarity

1 December 2025 by Sam Attard

Advena understands that the Medical Device Coordination Group (MDCG) is currently revising the guidance document MDCG 2020-16 rev.4 – Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746. This update is part of ongoing efforts to enhance clarity and improve consistency across EU medical device guidance. The current revision focuses … Read more

New Notified Body has been Designated under IVDR

4 November 2025 by Sam Attard

There has been a new notified body that have been designated under the IVDR. The new notified body: SGS FIMKO OY is from Finland. This new addition brings the total number of notified bodies under the IVDR to 19. More information about this notified body can be found using the following link

UPDATE: TEAM NB Update Position Paper regarding Technical Documentation under IVDR.

30 September 2025 by Sam Attard

TEAM NB has recently updated their Position Paper “Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746”. To offer some background to this document, TEAM NB has developed unified best practice guidance to clarify expectations for technical documentation submissions under the … Read more

MedTech Europe Proposal for a More Risk-Based Approach for Sampling under the IVDR

29 August 2025 by Sam Attard

Since the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) came into effect, the administrative workload for IVD manufacturers has increased significantly. Under the IVDR, Notified Bodies are required to review the technical documentation for Class B and Class C IVDs (used by laboratory professionals) through sampling during the validity of their certificates. Currently, … Read more

Concept of MDR Medical Device Regulation.

Important Announcement Concerning EU Device Registrations

29 August 2025 by Sam Attard

The Maltese Medicines Authority (MMA), in collaboration with other EU competent authorities, has introduced additional mandatory national measures to increase transparency of medical device and in vitro medical device registrations. New Mandatory Requirements: All medical devices including in vitro medical devices, regardless of classification must be registered with the competent authority by the authorised representative … Read more

New Notified Body has been Designated under the IVDR

1 August 2025 by Sam Attard

There has been a new notified body that have been designated under the IVDR. The new notified body: POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. is from Poland. This new addition brings the total number of notified bodies to 18. More information about this notified body can be found using the following link

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