Persuant to question 5 of the Q&A released by the EU Commission, manufacturers need to demonstarte that the conditions for the extension are fulfilled by means of a self-declaration, similar to the form produced for the MDR extension. The self-declaration should also state the end date of the transition peroid and should clearly identify the … Read more
The EU Commission has released an informative Q&A document intended to provide guidance on the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of EUDAMED, the obligation to inform in … Read more
There has been an update in the guidance document MDCG 2020-16 concerning the classification rules for in vitro diagnostic medical devices under regulation (EU) 2017/746. During this third revision, one can note there have been a few updates to this document. The most significant update is in the definitions section where there has been the … Read more
As many of our readers are aware, in July we had the privilege of visiting Bangkok to attend the 2024 edition of Asia Health. Asia Health was a premier gathering that brought together manufacturers, innovators, and stakeholders from across the healthcare sector in the ASEAN region. This dynamic event provided an invaluable platform to explore … Read more
The EU Commission has published a roadmap to illustrate the current planning for the gradual roll-out of EUDAMED. This roadmap is intended to give the relevant actors estimated timeframes of when each module will become mandatory for use. According to the roadmap published, the notice for the Actor, UDI/Devices, NB & Certificates and Market Surveillance … Read more
The MDCG has released a guidance document concerning the Clinical Evaluation of Orphan Medical Devices. As defined in the guidance document, for a device to be considered an orphan device, it must be a medical device that is specifically intended to benefit patients in the treatment, diagnosis and prevention of a disease that presents in … Read more
The MDCG has released a guidance document on the on the vigilance system for CE-marked devices DSVG 05 Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence. This follows the same format of the vigilance guidance documents that were released earlier this year concerning Devices for Cardiac Ablation, Coronary Stents … Read more
Are you Considering Selling your Medical Devices & IVD Devices in the European Union? Please remember that it is mandatory for medical device manufacturers located outside the EU to appoint an EU Authorised Representative. The EU REP plays a pivotal role in ensuring the compliance of devices produced by manufacturers who are located outside the … Read more
The EU Council has approved the very first legislations intended to harmonise Artificial Intelligence. Commonly referred to as the AI Act, this legislation intends on regulating this new emerging technology using a risk-based approach, i.e., the higher the risk, the stricter the rules. AI systems that have limited risk would be subject to light obligation, … Read more
The MDCG have released form templates relating to preliminary (re-)assessment of notified bodies. These templates are the following: The forms are relevant to assessing if the notified bodies meet the requirements to continue operating. There are different forms, concerning the different legislations, MDR and IVDR, and also forms depending on whether it is the first … Read more
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