How are medical devices without an intended medical purpose regulated under the MDR Annex XVI? Continue reading to learn more. The Medical Devices Regulation (MDR) 2017/745 has significantly changed the European Union’s (EU) regulatory landscape for medical devices. While prioritizing... read more
Following the end of a clinical investigation and irrespective of its outcome, the Regulation (EU) 2017/745 (MDR) and the International Organization for Standardization (ISO) 14155:2020, the Sponsor shall prepare a Clinical Investigation Report (CIR) or sometimes also called the Clinical... read more
The field of medical devices is continually evolving, with new technologies and innovative products constantly being developed to improve patient care and enhance the practice of medicine.In Spain, the regulatory landscape governing clinical investigations of medical devices has recently undergone... read more
In our latest article, MDx offers a comprehensive summary of the European Commission’s Q&A document, focusing on the implementation of Regulation (EU) 2023/607, which amends transitional provisions for specific medical devices and in vitro diagnostic devices under Regulations (EU) 2017/745... read more
The Medical Device Regulation (EU MDR) has introduced significant changes to the requirements for clinical evaluation of medical devices. This article will provide a comprehensive guide on incorporating the most relevant guidance from MDCG 2020-6, MDCG 2020-5, MDCG 2020-13, MEDDEV... read more
Since the implementation of the new EU MDR, there has been significant standardization in the processing of clinical investigation submissions throughout Europe. Each country, however, may have its own national provisions. This article is intended for clinical research experts who need... read more
Because the electronic system referenced to in Article 73 (Eudamed) will not be ready and completely functioning on the MDR’s effective date, this guideline covers the processes for safety reporting in clinical research in the absence of Eudamed. MDCG 2020-10... read more
Assisting with the EU Medical Devices Regulation Europe faces imminent shortages of medical equipment needed by hospitals and clinicians to treat patients. This dangerous disease affects both new and old devices. The EU institutions must take urgent and decisive action.... read more
This scientific opinion represents independent specialists’ opinions (MDR Article 106) on the notified body’s Clinical Evaluation Assessment Report (CEAR). Clinical Evaluation Consultation Process (CECP) is an extra aspect of conformity assessment by recognized organizations for high-risk devices (MDR Article 54... read more
This paper has been prepared thanks to the task force and endorsed during the general assembly meeting. It is a high level document. Improvements in patient care are more significant than new market potential for the manufacturer as a result... read more
The Mirror-MDCG-Clinical Working group, which includes members of 11 NBs, created this position paper. It was distributed to all NBs via CIRCABC. It has received approval from the Team-NB general assembly. Off-label usage is addressed in the Medical Device Regulation... read more
To create a consistent approach to the requirements of technical documentation submissions from manufacturers, members of Team NB reviewed the best practice guidance documents that each Team NB notified body member had submitted. They then prepared this best practice guidance... read more
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