ANSM Sees Uptick in Adverse Event Reports for Bayer IUD

France’s National Agency for the Safety of Medicines reported a major uptick in adverse advents associated with Bayer’s Mirena intrauterine device. Read More

The EMA Gets a New Home: Amsterdam

The European Union landed on Amsterdam as the new home for the European Medicines Agency headquarters, following three rounds of voting and a tiebreaker against Milan. Read More

CAMD Releases MDR/IVDR Implementation Roadmap

The EU’s Competent Authorities for Medical Devices, the umbrella group through which the EU’s national competent authorities work to enhance the single market for devices, released a new roadmap with a priority list of areas of focus for implementing the new European MDR/IVDR regulations. Read More

MedTech Europe Highlights Numerous Flaws, Needed Solutions for Brexit Plan

MedTech Europe is very concerned about the implications of a divergence in the regulatory framework for medical devices and… Read More

FDA Warns German Device Firm Over Adulteration, Misbranding

German-based devicemaker DRG Instruments drew a warning letter from the FDA and the agency said it would refuse entry of the company’s medical devices to the U.S. market because they were adulterated and misbranded. Read More

EMA Details Brexit Continuity Plan and Staff Retention Efforts

The European Medicines Agency will try to maintain “business as usual” for as long as possible throughout the U.K.’s planned exit from the European Union, according to a newly released continuity plan. Read More

FDA Warns Swedish Devicemaker on Complaints, Quality Audits

The FDA issued a warning letter to Euro-Diagnostica in Malmo, Sweden for its complaint and CAPA procedures as well as its quality audits, and said the company’s responses to observations from a January inspection were inadequate. Read More

MHRA Guidance Lists Steps for Notified Bodies to Assess Combo Products

Notified bodies will need to clear a few more hurdles when recommending a CE Mark for a drug-device combination in the UK. Read More

MHRA Plans Guidance on Co-Developing Medicines and IVDs

The UK’s Medicines and Healthcare products Regulatory Agency plans on issuing guidance on co-developing medicines and IVDs in the near future. Read More

MHRA Unveils Guidance on Human Factors in Device Design

The UK’s Medicines and Healthcare products Regulatory Agency published new guidance on human factors and usability engineering for medical device manufacturers — pulling back the curtain on the UK’s regulatory structure, and showing how various usability engineering strategies stack up against each other. Read More