News Letter - January 2024
As we enter the new year, we begin planning for the upcoming year, contemplating the Regulatory and Quality Assurance requirements for Medical Devices and IVDs. In this newsletter, we provide updates from regulatory authorities and standards organizations, aiding in your planning for compliance activities.
The MHRA has unveiled a roadmap for future UK regulatory implementation, offering insights into their thought process on Medical Device and IVD Regulatory activities. The guidance outlines extended timeframes for accepting CE marked medical devices and IVDs in the UK market.
In the EU, it’s crucial to note the deadline for Manufacturers placing CE mark certified Medical Devices on the market. Those not yet transitioning to the EU MDR 2017/745 must have a contract with an EU-approved Notified Body for recertification by May 2024.
EU MDCG Guidance Updates in January 2024
As of 14th January there were no new or updated MDCG documents issued by the EU for the month of January 2024. Here is a full list of the MDCG documents issued in December for those who may have missed these:
The Following New or Updated MDCG guidance documents were issued in December 2023:
MDCG 2023-7 – Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence
If you sell medical devices on the EU market you should check to ensure that you are following the latest guidance issued by the EU commission, MDCG documents can be found here.
MHRA Guidance Updates in January 2024
As of the 14th January 2024 the following MHRA guidance was updated in relation to Medical Devices and IVDs:
If you sell medical devices on the UK market you should check to ensure that you are following the latest guidance issued by the MHRA, MHRA documents can be found here.
Medical Device Standards updated in January 2024
Medical Device Standards issued or updated in January 2024: