Critical Catalyst

Safety reporting in clinical investigations of medical devices shall be performed in line with Article 80(2) of the .

On May 2020, it was published the MDCG 2020-10/1, outlining the procedures for safety reporting in clinical investigations of medical devices under the .

However, on October 2022 the Medical Device Coordination Group ( ) published an updated version of the MDCG 2020-10/1, the MDCG 2020-10/1 Rev 1.

This article highlights the updates included in the new revision, analysing the gaps between both documents.

https://criticalcatalyst.com/safety-reporting-in-clinical-investigations-a-gap-analysis-of-guidance-documents/

ISO Standards cover a huge range of activities, representing the distilled wisdom of people with expertise in their subject matter and providing the regulators with a sound basis to develop better legislation. ISO Standards are diverse, addressing from the shoe size we wear to the quality of air we breathe. The medical device sector is no exception. ISO has many International Standards and guidance documents aimed at helping the sector ensure safe and effective medical devices while meeting the multitude of national, regional and international regulatory requirements.

But how exactly is a Standard developed, reviewed and withdraw?

https://criticalcatalyst.com/understanding-the-iso-standards-lifecycle/

The European Union Court of Justice repealed the French requirement for the labelling of the precautionary measurement “Not to be used on the nappy-skin area of children under 3 years of age” on leave-on cosmetic products containing Phenoxyethanol. The labelling restriction related to Phenoxyethanol is no longer mandatory for products imported into France.

Read more @ https://criticalcatalyst.com/french-labelling-requirement-for-leave-on-products-containing-phenoxyethanol-repealed/