MHRA Release New Guidance on Post-Market Surveillance
The MHRA has released a guidance document regarding the Post-Market Surveillance. To offer some background to this newly released guidance document, the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 updates the UK Medical Devices Regulations (MDR) 2002 by introducing a new section (Part 4A) that outlines post-market surveillance (PMS) obligations for medical ...
MDCG 2024-16: Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices
Pursuant to the Q&A document published by the EU Commission, the manufacturer (or any relevant actor on behalf of the manufacturer) will need to inform the competent authority of a interruption or discontinuation of supply of certain medical devices and certain in vitro diagnostic medical devices using a form referred to as the ‘Manufacturer Information ...
MDCG 2024-15 Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED
A guidance document has been released on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED. To offer some background to this guidance document, Article 77(5) of the MDR mandates that sponsors submit a clinical investigation report to the Member States where the clinical investigation was conducted within one ...
Importance of Importers in the MDR/IVDR
Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), an importer is defined as any natural or legal person established within the European Union who places a medical device from a third country onto the EU market. The key criteria for an importer, as specified in the regulations, are: Obligations of Importers The obligations ...
MDCG 2024-14 Guidance on the implementation of the Master UDI-DI solution for contact lenses
The MDCG has recently published a guidance document regarding the implementation of the Master UDI-DI solution for contact lenses. To offer some background to this document, the Unique Device Identification (UDI) system, outlined in Article 27 of Regulation (EU) 2017/745 on medical devices (MDR), is designed to ensure robust identification and traceability of medical devices. ...
UPDATE: MDCG 2023-3 Rev. 1 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746
There has been an update to the guidance document MDCG 2023-3. Originally published last year, this document provides clarification on key terms and concepts outlined in Section 2, Chapter VII of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Its purpose is to establish a ...
Guidance on Borderline Products
The Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) provide comprehensive and detailed definitions that clearly outline what qualifies as a Medical Device and an In Vitro Diagnostic Medical Device. These definitions are essential, as they serve as the foundation for determining the regulatory pathway for products within the European Union. The ...
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
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 ...
MDCG 2024-13 – Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices
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. ...
MDCG 2024-11 Guidance on qualification of in vitro diagnostic medical devices
The MDCG has recently published a guidance concerning the qualification of in vitro diagnostic medical devices. The purpose of this guidance document is to clarify what products fall in scope of Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) or an accessory to an IVD. For a product to qualify as an IVD or ...
