MEDTECH Europe Issue Position Paper on Submission of vigilance reports to Notified Bodies under EU MDR & IVDR
Vigilance reports are a critical component of the post-market surveillance (PMS) system established by the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) to ensure medical device safety. Manufacturers are required to systematically collect, analyse, and review real-world data on devices placed on the EU market. ...
UPDATE: ISO 15223-1:2021
The latest amendment to ISO 15223-1:2021 (Amd 1:2025) has been published, introducing crucial updates to enhance global compliance, clarity, and consistency in medical device labelling. As regulatory requirements evolve, these changes are essential for manufacturers, authorised representatives, and other stakeholders to ensure seamless international acceptance of their products. The key updates include: The updated standard ...
UPDATE: MDCG 2020-16 rev.4 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
The guidance document MDCG 2020-16 has been recently updated. To offer some background to this guidance document, originally published in 2020, this guidance document provides clarification on the classification of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR), focusing on Annex VIII classification rules. It applies to diagnostic services performed on EU ...
Latest Consolidated Version of IVDR Published
The Latest version of the IVDR has been published in HTML format. The .pdf version is expected to be released in the near future. To access the latest consolidated version of the IVDR, click on the following link
Commission launches a public consultation and a call for evidence for EU Medical Devices evaluation
The European Commission has initiated a public consultation and call for evidence as part of a targeted evaluation of the EU legislation on medical devices and in vitro diagnostic medical devices. This consultation offers stakeholders the chance to share their views on the effectiveness of the current regulations and identify any potential shortcomings. The regulations ...
Consultation, EU, IVDR, MDR
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 ...
Classification Rationales
In the rapidly evolving European regulatory landscape, correct classification of medical devices and in vitro diagnostic medical devices (IVDs) under the Medical Device Regulation (MDR, EU 2017/745) and In Vitro Diagnostic Regulation (IVDR, EU 2017/746) is pivotal. Misclassification can lead to delays in market access, costly rework, compliance risks, and, most importantly, patient safety issues. ...
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 ...
EU Parliament Vote to Revise MDR and IVDR
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 ...
EU Publishes New Harmonised Standards for MDR and IVDR
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 ...
