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Establish a Medical Device Startup Company
Medical device startups play an essential role in revolutionising patient care and improving quality of life. If you share our passion for innovation, starting a medical device company could prove rewarding yet challenging – this article offers comprehensive guidance to help get one started.
June Newsletter 2023
EUROPEAN UNION Implementation of Regulation (EU) 2023/1194 on transitional provisions for products without an intended medical purpose | 21 June 2023 The deadlines for Annex XVI products mentioned in Implementing Regulation (EU) 2022/2346 has been extended in the...
Software As a Medical Device and Its Clinical Evaluation
INTRODUCTION: As technology advances across all healthcare fields, Software plays a significant role in all products. It is widely integrated into digital platforms serving both medical and non-medical purposes. Medical device software is one of three types of...
Regulations
MHRA Guidance on Stand-alone Software Medical Devices
Medical device apps are increasingly growing these days. MHRA has issued new guidance on the stand-alone software medical devices, including apps. This guidance is a crucial document for manufacturers and users of such medical devices.
Article 61 Clinical Evaluation in the EU MDR
Manufacturers must plan, carry out, and document a Clinical Evaluation in order to comply with the general safety and performance standards outlined in Annex I, as per Article 61. Clinical evaluation is a series of ongoing activities that use scientifically reliable techniques for the evaluation and analysis of clinical data in order to confirm the safety, clinical performance, and/or effectiveness of the medical device when used in accordance with the manufacturer’s instructions.
The ‘Blue Guide’ on EU product rules implementation 2022
The amended ‘Blue Guide’ on the application of the product rules 2022’ (“Blue Guide”) was released by the European Commission on June 29, 2022. The Blue Guide allows a better understanding of EU product regulations and their uniform and coherent...
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Registrations
MDCG Guidance for Manufacturers of Class I Medical Devices
This document is intended to serve as guidance for Class I medical device manufacturers (excluding custom-made devices) that sell products bearing their name or trademark on the Union market in order to comply with MDR requirements. This guidance should also apply when an importer, distributor, or any other legal entity takes on the obligations owed by manufacturers.
Requirements of Technical Documentation EU MDR
The technical documentation shall be presented in a clear, organised, readily searchable and unambiguous manner. It shall include all the elements listed in Annex II of EU MDR.
“Professional use” Test Kit – Procedure for registration in UK
"Professional use" Test Kit - Procedure for registration in UK Novel Corona Virus Disease 2019 (COVID-19) is a different variety of disease that has never been seen in humans before, impacting being a pandemic, and affecting the world since...
Authorised Representatives
Labelling Requirements – Swiss Authorized Representative
Label Written, printed, or graphic information appears either on the device itself or on the packaging of each unit or the packaging of multiple devices (Art. 2 point 13 MDR). Timeline for Information on Indication of CH-REP “on the device” or “in...
Swiss Manufacturer Obligations
1. Manufacturers outside Switzerland will need to appoint Swiss AR. 2. The Manufacturer will use commercially reasonable efforts to update its technical documentation for the devices, to comply with the requirements of the ordinance, and to...
Switzerland AR Responsibilities
Obligations of the Swiss Authorised Representative 1. Verify the DoC and technical documentation have been drawn up and where necessary conformity assessment procedure has been carried out. 2. Keep available a copy of the technical documentation,...