Conducting a clinical investigation in medical devices within the European Union (EU) requires a Sponsor, who has responsibilities before, during and after the clinical investigation.
The MDCG 2022-19 was published on December 2022. This document indicates a series of templates that should be used for performance study applications under the IVDR, while the respective EUDAMED module is not fully functional.
Safety reporting in clinical investigations of medical devices shall be performed in line with Article 80(2) of the EU MDR. 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 EU MDR. However, on October 2022 the Medical Device Coordination Group (MDCG) 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.
If a medical device manufacturer is not established in a Member State, the devices can only be placed on the Union market if the manufacturer designates an authorised representative. The authorised representative plays a pivotal role in ensuring the compliance of the devices with EU regulation, serving as point of contact. The obligations and responsibilities of authorised representative are outlined on Article 11 of both MDR and IVDR, but clarification of relevant requirements is described in MDCG 2022-16 of October 2022.
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?
The Commission published the Implementing Regulation (EU) 2022/2347, laying down rules for the reclassification of several active products without an intended medical purpose mentioned in MDR annex XVI.
The United Kingdom has taken a significant step in regulating the use of Butylated Hydroxytoluene (BHT) in cosmetic products. This move is crucial for distributors, manufacturers, and importers to ensure compliance and maintain the safety of their products in the UK market.
On March 12, 2024, the Health and Safety Executive (HSE) updated the GB Mandatory Classification List (MCL) by adding 25 new chemical substances, as mandated by Article 37 of the GB Classification, Labelling and Packaging (CLP) Regulation. This update impacts substances identified as cosmetic ingredients with proposed Carcinogen, Mutagen, or Reprotoxic (CMR) classifications under Article 15 of the UK Cosmetics Regulation (UKCR). Notably, 2-ethylhexanoic acid and its zinc salt, along with Dimethyltolylamine, are among those facing potential bans and additions to the UK Cosmetics Regulation’s Annex II. These changes will come into effect on September 2, 2025.
The Scientific Committee on Consumer Safety (SCCS) published the Preliminary Opinion on new coating for Titanium Dioxide (nano). It declared the data was not enough to draw conclusions regarding the safety of this alternative coating, as more evidence of similarity to other nanomaterials is necessary.
Cyclic volatile methyl siloxanes (cVMS) have raised environmental concerns because of their persistence and bioaccumulative properties. In light of these concerns, the European Union has extended restrictions on substances like D4, D5, and D6 in cosmetic products. New regulations will further limit the concentration of these compounds in both rinse-off and leave-on products, with compliance deadlines set for 2026 and 2027.
The SCCS was tasked by the European Commission to evaluate if the safety levels for Citral, determined through QRA2 based on skin sensitization induction, are sufficient to safeguard consumers. A preliminary opinion was released.
Benzophenone-4 is commonly known as a UV-filter in cosmetic products. Learn what the final opinion of SCCS states about Benzophenone’s safety profile as a UV-filter in cosmetic products.
The U.S. Food and Drug Administration (FDA) has announced that it is providing a new laboratory testing method to assess the quality of finished hand sanitizers. Moreover, the FDA has issued a new press release on August 27th 2020, where it warns consumers about hand sanitizers packaged in food and drink containers. Earlier this month, the FDA expanded hand sanitizer warnings to include 1-propanol contamination.
The new coronavirus SARS-CoV-2 has led to an increasing demand of hand sanitizers. Nevertheless, not all hand sanitizers made available in the market are safe. The U.S. Food and Drug Administration (FDA) has issued a public warning to consumers and health care providers for possible contamination of hand sanitizers with methanol. The FDA advises the public not to use such hand sanitizers, because methanol is a dangerous and toxic substance.
In March 2020, the RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial was established as a randomised clinical trial to test a range of potential treatments for COVID-19, including low-dose dexamethasone (a steroid treatment).
Transmission pathways of coronavirus disease 2019 (COVID-19) were studied by analyzing the trend and mitigation measures in the three epicenters. Results show that the airborne transmission route is highly virulent and dominant for the spread of COVID-19. The difference with and without mandated face covering represents the determinant in shaping the trends of the pandemic. Mitigation measures, such as social distancing implemented in the United States, are insufficient by themselves in protecting the public.
Lockdowns and other distancing measures have had resounding success at thwarting the new coronavirus, according to two independently conducted studies that examined different countries and measures of effectiveness.
20 EU countries have reported to the European Chemicals Agency (ECHA) and the European Commission (EC) that the COVID-19 pandemic has led to an increased number of non-compliant hand disinfectants on their markets since March 2020.
