Europe – The Future of Europe’s Medical Technology Regulations
MedTech Europe and its members fully support the objectives of the medical technology regulations, In Vitro Diagnostic Medical Devices Regulation 2017/746/EU (IVDR) and Medical...
Europe – Notified Bodies Survey on certifications and applications (MDR/IVDR)
To support monitoring and analyzing the availability of medical devices on the EU
market in the context of the implementation of medical devices and in...
New Zealand – Guideline on the Regulation of Therapeutic Products in New Zealand
Pharmacovigilance is defined by the WHO as the science and activities relating to the
detection, assessment, understanding and prevention of adverse events or any medicinerelated...
USA – FDA Clears First COVID-19 Home Antigen Test
Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) antigen test for COVID-19. ACON Laboratories’ Flowflex COVID-19 Antigen Home...
USA – FDA recognizes three new international medical device software security standards
The US Food and Drug Administration (FDA) has recognized three new standards related to software security on medical devices. The standards address taking a...
Europe – Un nouveau organisme notifié au titre du règlement (UE) 2017/746
Un nouveau organisme notifié au titre du règlement (UE) 2017/746
Europe – 40ème organisme notifié au titre du règlement (UE) 2017/745
40ème ON notifié au titre du règlement 2017/745
USA – FDA reiterates guidance plans on distributed and point-of-care manufacturing
The US Food and Drug Administration (FDA) this week reiterated its plan to issue draft guidance spelling out how it intends to regulate distributed...
Europe – Notified body perspective: Evaluating uses for real-world data
Real-world data (RWD) can provide useful information that may be included in clinical data submissions, but the greatest value may be during the postmarket...
USA – FDA extends regulatory flexibilities for PMA, HDE modifications
The US Food and Drug Administration (FDA) has published a final guidance that extends its pandemic-era policy of allowing manufacturers to make certain modifications...
