Addressing the strict rules for IVD manufacturers

La Libre Belgique interviewed Dirk Stynen regarding the new regulations for IVD and how Qarad continues to fulfil the manufacturers needs.

Brexit and the Impact on the IVD and MD Industries

The United Kingdom (UK) leaves the European Union (EU) on January 1, 2021. Manufacturers wanting to begin or continue business within the UK need to understand the implications of this move and should start making preparations today.

EUDAMED Actor Registration Module LIVE!

The European Commission launched the EUDAMED Actor Registration Module. Manufacturers, Authorised Representatives and/or Importers can now register in EUDAMED and obtain their Single Registration Number (SRN).

MDCG Guidance on IVDR Classification Rules released!

On 13 November 2020, the European Commission released MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (IVDR).

EUDAMED Actor Registration Module!

On 20 October 2020, the European Commission launched a new webpage explaining the steps necessary for actors to start registering in EUDAMED as of 1 December 2020.

MHRA Guidance on regulating Medical Devices!

MHRA published its Guidance on Regulating medical devices from 1 January 2021, thus after the Brexit transition period ends. The UK will have its own regulatory regime as of 1 January 2021, and it will include a number of changes to how medical devices and IVDs are placed on the market in Great Britain.

EUDAMED Actors Registration Module!

On 18 August 2020, the European Commission’s Medical Devices Coordination Group (MDCG) published MDCG 2020-15 MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States.

UDI FAQ

The European Commission has published a Q&A document explaining how the Unique Device Identification (UDI) system will work under the EU medical devices Regulations 2017/745 and 2017/746.

Common Specifications for the reprocessing of single-use medical devices under the MDR!

The European Commission issued the implementing regulation 2020/1207 establishing common specifications for the reprocessing of single-use medical devices under the Medical Device Regulation (MDR). It enters into force on 29 August 2020 and will fully apply on date of application of the Medical Device Regulation 2017/745, i.e. 26 May 2021.

New MDCG Guidance Documents!

MDCG published a template for clinical evaluation assessment reports (CEAR), and a guidance explaining how Notified Bodies may make use of MDSAP audit reports when performing surveillance audits under Regulation 2017/745 Medical Devices Regulation (MDR) and Regulation 2017/746 In Vitro Diagnostic medical devices Regulation (IVDR).

Fact sheet on Transparency and Public Information!

The European Commission has released a fact sheet explaining what information will be made public according to transparency obligations under Regulation 2017/745 Medical Devices Regulation (MDR), even though some of those requirements will not be applicable until the European database on medical devices (EUDAMED) is fully functional.

ISO Technical Report 20416:2020 Published!

The International Organization for Standardization (ISO) published the Technical Report 20416:2020 on Medical devices - Post-market surveillance for manufacturers.

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