Europe

NHS Drafts Code of Conduct for AI, Data-Driven Technologies

England’s National Health Service rolled out a voluntary code of practice for data-driven technology such as artificial intelligence and other data-driven applications and clinical support tools. Read More

German Devicemaker Meluna Falls Short on Quality Standards

German menstrual cup maker Meluna fell short on medical device reporting, complaint handling, and CAPA procedures, the FDA said in a six-item Form 483 following an inspection of the firm’s Haundorf facility. Read More

FDA Cites Alber for Lack of Design Change Procedures

Lack of design change procedures and validation as well as inadequate complaint handling resulted in a 483 for German devicemaker Alber during an inspection of the firm’s facility in Albstadt, Baden-Wurttemberg. Read More

Switzerland’s Bioptron Fails to Control Product, Racks Up 14-Item Form 483

Swiss medical light therapy manufacturer Bioptron failed to properly deal with products that didn’t meet specifications and it lacked proper documentation, FDA investigators found in an inspection of the company’s Wollerau facility. Read More

UK Unveils ‘No Deal’ Brexit Contingency Plan

The UK’s Department of Health and Social Care (DHSC) released a contingency plan in anticipation of a possible “no deal” Brexit situation that could… Read More

UK Brexit Implementation Period Would Mean Business As Usual

The UK’s Medicines and Healthcare products Regulatory Agency released guidance on how EU mutual recognition agreements would affect devicemakers during the Brexit implementation period. Read More

MedTech Europe Raises New Concerns Over MDR/IVDR Timelines

MedTech Europe sounded a new alarm about the limited time available to implement the EU’s new medical device regulations and in vitro diagnostic regulations that go online May 2020 and May 2022 respectively. Read More

France to Beef Up Clinical Trial Requirements for Flow Diverter Stents

France’s National Agency for the Safety of Medicines (ANSM) is calling for more exhaustive clinical studies prior to CE marking of flow diverter stents that are implanted to treat intracranial aneurysms. Read More

Time Is Running Out to Prepare for New EU MDR/IVDR: MedTech Europe

One year after the EU finalized its new medical device and in vitro diagnostics regulations there has been little progress in helping industry transition to the new regulations, according to MedTech Europe. Read More

Parliament Proposes EU-Wide Health Technology Assessments

Draft legislation from the European Parliament calls for joint assessments of new health technologies including medical devices rather than the current system of individual assessments by EU member states. Read More