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Q&A Published by the EU Commission Regarding Information Obligation In Case of Interruption or Discontinuation of Supply of Certain Medical Devices or In-Vitro Diagnostic Devices

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The EU Commission has released a Q&A document regarding the Information Obligation in Case of Interruption or Discontinuation of Supply of Certain Medical Devices or In-Vitro Diagnostic Devices, a measure first introduced in the amendment (EU) 2024/1860. To offer some background to this document, earlier this year, an amendment to the IVDR and MDR, dubbed … Read more

Concept of MDR Medical Device Regulation.

MDCG 2024-13 – Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices

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The regulatory status of ethylene oxide (EtO) for sterilizing single-use medical devices during manufacturing has been examined within the scope of the Review Programme under Regulation (EU) 528/2012 on biocidal products (BPR). EtO is widely used to sterilize various medical products, including medical devices, in vitro diagnostic medical devices (IVDs), medicinal products, and combination products. … Read more

Concept of MDR Medical Device Regulation.

UPDATE: MDCG 2022 – 5 Rev. 1 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices

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There has been an update to the guidance document MDCG 2022-5 concerning guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices. The update includes the addition of products specifically intended for the cleaning, disinfection or sterilisation of medical devices in section 1.2.6.1 to the list of examples of … Read more

EU Parliament Vote to Revise MDR and IVDR

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The EU Parliament has adopted a resolution to revise the MDR and IVDR to address the ongoing challenges regarding implementation and support patient access to essential medical devices by 2025. The EU Parliament’s proposed amendments to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are timely, balancing much-needed reform with a commitment … Read more

EU Publishes New Harmonised Standards for MDR and IVDR

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To provide some context, a harmonized standard is a European standard developed by recognized European Standards Organizations such as: These standards are created based on a formal request from the European Commission. They are crucial for manufacturers, economic operators, and conformity assessment bodies, as they offer a recognized way to demonstrate compliance with relevant EU … Read more

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MHRA Submit Draft Post-Market Surveillance Statutory Instrument to Parliament

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In addition to the consultation on the future regulation of medical devices in the UK, the government plans to introduce legislation in 2024 that will strengthen Post-Market Surveillance (PMS) requirements in Great Britain ahead of broader regulatory reforms. This initiative reflects the government’s commitment to enhancing patient safety as part of the upcoming medical device … Read more

Concept of MDR Medical Device Regulation.

UPDATE: MDCG 2021-25 Rev. 1 Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC

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There has been an update to the guidance document MDCG 2021-25 concerning the application of the MDR to legacy devices. To offer some background to this guidance document, the transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR) have been revised by Regulation (EU) 2023/607. Notably, the transitional period has been extended to either … Read more

Concept of MDR Medical Device Regulation.

MDCG 2024-12 Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams

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The MDCG has released a guidance document concerning Corrective and preventive action (CAPA) plan assessment. This guidance document is designed for conformity assessment bodies (CABs), notified bodies (NBs), designating authorities (DAs), and Joint Assessment Teams (JATs) involved in the implementation of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro … Read more

Concept of MDR Medical Device Regulation.

New Notified body has been designated under MDR

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A new notified body has been designated for the MDR. The new notified body, NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC) (NB 1011), is based in Hungary. This new addition brings the total number of notified bodies designated under MDR to 50. More information on the notified body can be … Read more

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