The European Commission has published a number of guidance documents related to how manufacturers, authorised representatives and importers (‘economic operators’) will be able to access and register with the ‘actor registration’ module of Eudamed from 1 December 2020. A new webpage has been set up within the Eudamed website, relating only to the actor registration…
The US Food and Drug Administration (FDA) has published draft guidance to propose select updates to its biocompatibility recommendations, to assist manufacturers in preparing premarket approval applications (PMAs), humanitarian device exemption (HDE) applications, investigational device exemption (IDE) applications, premarket notification (510(k)) submissions, and De Novo classification requests for medical devices that come into direct contact…
The European Commission has released guidance for manufacturers of insulin infusion pumps and integrated-meter systems to spell out the reporting requirements under the EU’s Medical Device Regulation (MDR, 2017/745). The guidance, reference DSVG 05, ‘Guidance on the vigilance system for CE-marked medical devices: Insulin Infusion Pumps and Integrated meter systems’, outlines specific scenarios that should…
Progress has been made on several fronts in relation to the roll-out of regulations and guidance for the Medical Device Regulation (MDR, 2017/745) in recent weeks. Firstly, the 16th and 17th MDR Notified Bodies have been named on the NANDO database, these being DQS Medizinprodukte GmbH, Germany, making it the sixth Notified Body to be…
Donawa Lifescience President, Maria E. Donawa M.D., has authored a new White Paper for inclusion in BSI’s Compliance Navigator series, titled ‘Medical device clinical investigations – What’s new under the MDR?’ The 30 page document discusses the important new requirements for pre-market and post-market clinical investigations included in the European Medical Device Regulation (MDR, 2017/745),…
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published in its website an overview of the post-Brexit regulations that will apply to medical devices in the event of a ‘no deal’ or ‘hard’ Brexit. It confirms that the UK will leave the European Union (EU) on 31 December 2020, and so the new…
Two reports do not provide easy reading for UK MedTech, as the government warns about post-Brexit device shortages and a survey finds UK SMEs still unprepared for the MDR, despite having an extra year to prepare, thanks to the coronavirus. In a letter to suppliers, Steve Oldfield, Chief Commercial Officer at the Department of Health…
The US Food and Drug Administration (FDA) has announced the user fees that will apply to medical devices from 1 October 2020 until 30 September 2021. The fees will be: † For small businesses with an approved SBD. ‡ Note: all types of 510(k)s…
More than two years after the US Food and Drug Administration (FDA) first proposed an alternate safety and performance based pathway for certain well-understood medical devices, the agency has finalized the first two device-specific guidelines establishing performance criteria to support 510(k) clearance via the new pathway. The two final guidelines provide performance criteria for cutaneous…
The European Commission has launched a new Medical Devices website, hosted on the portal of the Directorate-General for Health and Food Safety (DG SANTE). The website contains information and advice for all stakeholders in the medical devices and in vitro medical devices value chain with respect to their roles and responsibilities within the context of…
