Europe

Validation Issues Uncovered at Dannoritzer Medizintechnik

Germany’s Dannoritzer Medizintechnik received a six-item Form 483 following a Feb. 5 to Feb. 8 inspection of its Baden-Wuttemberg facility for inadequate validation and process control procedures for its surgical equipment. Read More

EC Adds Four Devices to Manual on Borderline and Classification

The European Commission added four new products it considers devices to its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices, including several related to contraception. Read More

European Commission Clarifies UDI Manufacturer Obligations Under New Regs

Distributors and importers that assume the obligations of device manufacturers also assume responsibility for… Read More

FDA Hits French Devicemaker for MDRs

Cair LGL, a manufacturer of medical devices and equipment for hospitals, failed to properly submit MDRs, adequately maintain complaint files or evaluate complaints, the FDA said following a February inspection of its facility in Lissieu, France. Read More

UK’s MHRA Issues Guidance on How to Comply With EU MDR

Some medical devices that don’t have an intended medical purpose — such as non-prescription colored contact lenses — will be required to comply with the EU’s new regulations for medical devices by May 26, 2020, the UK’s Medicines and Healthcare products Regulatory Agency said in a new guidance on Annex XVI of the EU’s Medical Device Regulation. Read More

European Commission Issues EU MDR/IDVR Implementation Plan

The European Commission issued a new work plan for implementation of EU regulations on medical devices and in vitro diagnostics. Read More

MHRA Seeks Industry Input on No-Deal Brexit Provisions

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is seeking industry feedback on a potential no-deal Brexit scenario in which the agency would function as a medical device and medicine regulator on its own. Read More

Allergan Recalls Implant in EU for Loose Silicone Particle

Allergan recalled its Ozurdex 700 mg intravitreal implant because a single loose silicone particle may become detached from the needle sleeve during administration of the implant and may be delivered into the eye along with the implant. Read More

Czech Republic Launches New Portal to Track Medical Devices

The Czech Republic’s Ministry of Health is launching a new web portal to track medical devices in the country. Read More

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