Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

Europe – MDCG 2021-25 : Regulation (EU) 2017/745 – application of MDR requirements to...

At its meeting on 27/28 May 2021, the MDCG set up an ad hoc task-force regarding the application of transitional provisions laid down in Article...
CDER Outlines Drug Safety Priorities

USA – Defining critical tasks for human factors validation tests of combination products

There are some differences in how the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), focused on drug and...

USA – FDA issues proposed OTC hearing aid rule

The US Food and Drug Administration (FDA) has issued a long-awaited proposed rule to create a new regulatory category that would allow the sale...
Contact Lenses: CDRH Drafts Guidance on Performance Criteria to Support 510(k)s

USA – FDA says IRB review still needed for IVD studies involving human specimens

The US Food and Drug Administration (FDA) reiterates that clinical studies of in vitro diagnostic devices (IVDs) using leftover, "deidentified" human specimens still have to be...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – MHRA launches public consultation on future of medical device regulation

Launched today by the Medicines and Healthcare products Regulatory Agency (MHRA), the 10-week consultation gives everyone the opportunity to draw on their own experiences...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – European IVDR application partially postponed

The European Commission has proposed delaying compliance deadlines for the In-vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), which would allow some manufacturers more...

USA – FDA nixes GUDID submission requirements for class I consumer healthcare devices

Manufacturers of class I medical devices considered to be consumer healthcare products will get a reprieve from complying with the US Food and Drug...
CLASSIFICATION DES DM : Comparaison DDM/RDM

Europe – IVDR: Commission proposes to delay implementation amid ‘grave’ notified body shortage

Amid concerns of a market collapse and a "grave shortage" of notified body capacity, the European Commission on Thursday proposed to delay the implementation...
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs

USA – Microspheres for knee osteoarthritis get breakthrough status

Varian announced today that it received FDA breakthrough device designation for its Embozene microspheres for treating knee osteoarthritis. Palo Alto, California-based Varian, a Siemens Healthineers (ETR:SHL) company,...

France – L’Institut Curie s’apprête à passer à l’analyse par IA de toutes les...

PARIS (TICsanté) - L'Institut Curie s'apprête à passer à l'analyse par une intelligence artificielle (IA) de toutes les lames histologiques de cancer du sein...

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