Tag Archives: medical devices

French medicines regulator produces first in Europe medical devices cybersecurity guidelines

France’s medicines regulator, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), has released draft guidelines, currently subject to a public consultation, setting out recommendations for manufacturers designed to help prevent cybersecurity attacks to medical devices. Notably, the draft guidelines are the first instance of recommendations released by a national regulator … Continue Reading

UK regulator provides further ‘no deal’ Brexit guidance for medical devices regulation

On 26 February, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published further guidance (available here) setting out the anticipated regulation of medical devices in the UK, should the UK leave the EU without a deal (Guidance).  This Guidance will apply from ‘exit day’ (expected to be 11 p.m. 29 March 2019) subject to … Continue Reading

EU Expected to Amend RoHS2 Directive for Used and Refurbished Medical Devices

The European Commission is expected to present, in early 2017, a proposal to amend the RoHS2 Directive.  The amendment would remove the July 22, 2019 deadline for the supply and resale of non-compliant electronic medical devices, in-vitro diagnostic medical devices (IVDs) and monitoring and control instruments that were first marketed in, or imported into, the … Continue Reading

FDA Issues Long-Awaited Draft Guidance Documents Concerning Internet/Social Media

Recently, the United States Food and Drug Administration (FDA) released two long-awaited draft guidance documents pertaining to internet and social media: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices Internet/Social Media Platforms with Character Space Limitations–Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices. The first draft guidance … Continue Reading

New UK Guidance on Software as a Medical Device

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on software as a medical device, including apps.  The guidance aims to assist those working in healthcare, and software developers, to determine whether a specific piece of stand-alone software or an app constitutes a medical device.  The MHRA provides illustrative examples of software, … Continue Reading
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