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.
Ingredient: SODIUM CHLORITE
Date of publication: 20/01/2025
On January 20, 2025, the European Chemicals Agency (ECHA) received a proposal from Hungary to classify Sodium Chlorite as Mutagenic 2. The proposal is open for comments until March 21 2025.
Ingredient: RESORCINOL
Date of publication: 20/01/2025
On January 20, 2025, the European Chemicals Agency (ECHA) received a proposal from France to classify Resorcinol as Endocrine Disruptor for human health. The proposal is open for comments until March 21 2025.
Ingredient: HEXAMETHYLINDANOPYRAN
Date of publication: 27/01/2025
On January 27, 2025, the European Chemicals Agency (ECHA) received a proposal from France to classify Hexamethylindanopyran as Reprotoxic 1B. The proposal is open for comments until March 28 2025.
Ingredient: AMINOMETHYL PROPANOL
Date of publication: 16/12/2024
On December 16, 2024, the European Chemicals Agency (ECHA) received a proposal from Austria to classify Aminomethyl Propanol as Reprotoxic 1B. The proposal is open for comments until February 14 2025.
Ingredient: P-CYMENE
Date of publication: 10/1/2025
P-cymene may be banned from cosmetics as its proposed classification as Reprotoxic 1B is under review and is expected to be approved.
Ingredient: SALICYLIC ACID
Date of publication: 13/1/2025
On January 13 2025, the Scientific Committee on Consumer Safety (SCCS) assessed the safety of Salicylic Acid for children’s between 3 and 10 years old. The deadline for comments is set to March 10, 2025.
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.
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.
Antibody studies might underestimate the share of a population that has been infected with SARS-CoV-2. Most antibody tests have been validated using blood samples from people hospitalized with severe disease. But these individuals, who make up only a small fraction of infected people, might have higher levels of antibodies circulating in their body than have people with mild or no symptoms.
