USA – FDA asks manufacturers to develop risk management plans to avert shortages

The US Food and Drug Administration (FDA) has issued draft guidance that spells out which types of drugs and medical devices are vulnerable to...
ANVISA will implement new rules for medical device modifications in Brazil

Brazil – Brazil’s ANVISA repeals medical device regulations related to the coronavirus pandemic

Brazilian medical device market regulator ANVISA announced the repeal of several regulations and requirements related to the COVID-19 pandemic which have been deemed no...
Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR) on March 11th, 2020

Europe – Europe Medical Devices Regulation (MDR) CE Marking Regulatory Process

In order to commercialize medical devices in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory...

USA – FDA moves forward with Voluntary Improvement Program to bolster medical device quality

The US Food and Drug Administration has issued new draft guidance to establish a full-blown voluntary program for improving quality-related processes in medical device...

France – Cegedim Santé lève 65 millions d’euros et acquiert l’entreprise de télémédecine MesDocteurs

PARIS (TICsanté) - Le groupe Cegedim a annoncé le 16 mai avoir signé un "protocole d'investissement" avec les groupes de protection sociale Malakoff Humanis,...
Advice for Management of Clinical trials in relation to Coronavirus

UK – Medical devices: UK approved bodies

Approved bodies under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) for medical devices...
Increased requirements for clinical evidence under the new Medical Devices Regulation (MDR)

Europe – IVDR: Commission adds risk management standard to harmonized standards list

The European Commission last week updated its list of officially recognized harmonized standards for in vitro diagnostics in order to satisfy conformity requirements under the In Vitro...
FDA Received 6,000 Reports About Essure in 2018

France – Implants Essure® : l’étain mis en cause dans la toxicité du dispositif

Mis sur le marché en 2002 et retirés en 2017, les implants Essure® étaient proposés aux femmes de plus de 45 ans ayant déjà...
Singapore HSA revises guidance and technical documents

Singapore – Singapore issues new guidance for software as a medical device

As software has begun to have an increasingly important role in many medical devices that rely on it for safe and effective function, Singapore’s...
New guidance on biologics affects authorized generics

USA – Mirvie’s Preeclampsia Test Designated an FDA Breakthrough Device

South San Francisco, Calif.-based Mirvie has secured the FDA’s Breakthrough Device designation for its test to indicate a woman’s risk of developing preeclampsia during...

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