The European Commission’s Medical Device Coordination Group (MDCG) has published long-awaited guidance, MDCG 2020-16, that explains how to classify products for compliance with the EU’s In Vitro Diagnostics Regulation (IVDR, 2017/746). The IVDR is replacing the classification system from the In Vitro Diagnostics Directive (IVDD, 98/79/EC) with a risk-based system, which will require the reclassification…
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published on its website full details of how the device registration system for the UK will operate post-Brexit, from 1 January 2021. As already known, only UK entities will be allowed to make the device registrations, these being either UK device manufacturers, UK Responsible Persons…
Team-NB (the European association of notified bodies) has published a position paper on the IVD Regulation (2017/746) date of application, indicating that their member Notified Bodies would support maintaining the current May 2022 date of application, provided that the following conditions are met by the end of 2020: The tools necessary to perform conformity assessments…
The catalog collates a variety of regulatory science tools that the FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Labs (OSEL) developed and plans to expand as new tools become available. “These tools expand the scope of innovative science-based approaches to help improve the development and assessment of emerging medical…
Sponsors of medical devices that are electrically powered or have electronic circuitry need to include 11 categories of safety information in their premarket submissions, the US Food and Drug Administration (FDA) has said in a draft guidance document intended to replace the Agency’s 2016 guidance on electromagnetic compatibility of devices. The guidance applies to submissions…
Under the IVDR (2017/746) manufacturers will need to state on their labels when the device is intended for self-testing or for near-patient testing, and for certain rapid tests when they are not intended for self-testing nor for near-patient testing. MedTech Europe (MTE) wants to make this more effective by providing industry with agreed symbols for…
The International Medical Device Regulators Forum (IMDRF) made further progress towards global harmonization of device standards at its most recent meeting, held for the first time as a virtual conference due to COVID-19 restrictions. Among other actions at the September meeting, hosted by Singapore, IMDRF approved the final draft of a document on conformity assessment…
Donawa Lifescience Consulting (DLC), headquartered in Rome, Italy, has announced the opening of a company in Great Britain (GB), Donawa Lifescience Ltd., to provide non-UK companies with ‘United Kingdom Responsible Person’ (UKRP) services as an easy initial pathway to the post-Brexit medical device market in Great Britain. Following the publication of the UK Medicines and…
The UK government has published a further set of draft amendments to the Medical Devices Regulations 2002 (as previously amended), for which a draft amendment was published in late 2019 (the ‘Amendment of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019’), but which has now been further amended in ‘The Medical Devices (Amendment etc.)…
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…
