Medical Devices – EU Regulatory Framework

Medical Devices and In Vitro Diagnostic Medical Devices have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. The European regulatory framework ensures the safety and performance of medical devices and facilitates patients’ access to devices in the European market. To keep up with advances in science and technology, 2 new Regulations are replacing the 3 existing Directives in the coming years.

Medical Devices – U.S. Regulatory Framework

The Food and Drug Administration (FDA) is the authority regulating Medical Devices in the U.S., to ensure their safety and effectiveness. Medical devices are divided into three classes (I, II and III) and this classification defines the regulatory requirements for each device type.

Medical Devices – Brazil Regulatory Framework

Brazil represents the biggest market for medical devices in South America. Selling and marketing medical devices in Brazil requires several actions and compliance with legislation and standards, which can be a complex process.

Medical Apps CE marking

CE marking indicates that your product has been assessed to meet EU safety, health and environmental protection requirements and that it can be freely traded within the European Economic Area (EU + EFTA countries). It is valid for products developed both inside and outside the EEA. It is required for all products, including software/apps, that fall under the definition of a medical device.

EUDAMED status update

Updates continue to be issued from the European Commission concerning EUDAMED in light of the current COVID-19 pandemic. The latest information sets new expectations about the availability of modules and expected activity.

EU MDR – Person Responsible for Regulatory Compliance (PRRC)

The EU Medical Devices Regulation (MDR) lays down the rules regarding the placing on the market, making available on the market or putting into service of medical devices and accessories for such devices. When compared to the prior applicable Directives, the MDR (and also IVDR) makes it mandatory for manufacturers to have within their organizations at least one Person Responsible for Regulatory Compliance.

Swiss Medical Devices Regulation Revision

A revision of the Medical Devices Ordinance (MedDO) has been approved by the Swiss Federal Council. This revision will take effect on 26th May 2021, along with a new Ordinance on Clinical Trials for Medical Devices (ClinO-MED). The aim of this revision is to align and harmonize it with the European Union Medical Devices Regulation (MDR) and consequently simplify market trading and maintain Switzerland’s market participation.

EU Medical Devices Regulation – Unique Device Identifier (UDI)

In 2017, two Regulations on medical devices (MDR) and in in vitro diagnostic medical devices (IVDR) entered into force in the European Union (EU), establishing a modernized and more robust EU legislative framework and safeguarding a better public health protection and patient safety. According to the these Regulations, the Unique Device Identifier (UDI) will be mandatory for all medical devices and in vitro medical devices.

Brazil – Class II Medical Devices – New Resolution

A new Resolution of the Collegiate Board of Directors (RDC No. 423/2020) has been published by Brazil’s National Agency of Health Surveillance (ANVISA). This new Resolution announces the elimination of the ‘Cadastro’ pathway regarding the registration of medical devices (Class II) and IVDs, substituting it with a notification registration system.

BREXIT – Impact on Medical Devices placed in the UK market

From 31 of December 2020, the UK will be regarded as a third country and not a Member State of the European Union. There will be some changes regarding medical devices placed in the UK. The UK’s MHRA has published guidance regarding the regulation of medical devices from 1 January 2021, where it explains what changes and what there is to know about placing a medical device in the Great Britain, Northern Ireland and EU markets.


Standards for Cosmetic Safety Assessment and Efficacy Claims in China

Since the beginning of the year, the new Cosmetics Supervision and Administration Regulation (CSAR) has come into force in China. The prohibition of animal testing in certain cosmetics and the publication of guidelines for the safety assessment of cosmetics and testing of efficacy claims are two of the main issues included in this new Chinese legislation affecting cosmetic products.

Probiotic, Prebiotic and Postbiotic Claims in Cosmetic Products

Microbiome claims such as, probiotic, prebiotic, postbiotic and other related terms are becoming more and more popular in the beauty industry. But what does it really mean? How can a cosmetic company justify such claims? How are these products regulated in terms of their safety and quality standards?

United States (U.S.) Cosmetics Regulation

Cosmetics and personal care products were regarded as underregulated in the United States (U.S). But in 2019, the new federal bill HR 4296 (Safe Cosmetics and Personal Care Products Act) came, replacing the previous HR 2359, and introducing a progressive, robust regulatory framework for cosmetics and personal care products.

Nanotechnology in Cosmetics

Nanotechnology is a growing business worldwide. Nanomaterials are increasingly used in cosmetics and personal care products. Nanomaterials are similar to other chemicals/substances, but there are risks associated to specific nanomaterials and their use. In the EU, cosmetic products containing nanomaterials may have to be notified by the Responsible Person six months before being placed on the market.

The Impact of SCIP in Cosmetics

Since January this year, it is mandatory for companies who produce, assemble, import or distribute products containing SVHC (above 0.1% w/w) in the European Union market to notify ECHA using the SCIP database.

Sustainable Cosmetic Products

Consumers are increasingly looking for transparency and authenticity and the cosmetic industry is no exception. Choosing clean and sustainable ingredients and proper cosmetic and personal care products labelling are important steps to achieve the sustainable brand status. All three pillars of sustainability should be considered: environmental protection, corporate social responsibility and ethical governance.

Creating a “Zero Waste” Cosmetic Industry. Is it possible?

Climate changes, pollution, waste management, recycling are some of the terms we see frequently on the news and tabloids. Consumers are concerned with the planet and are demanding more innovative and sustainability ideas (“eco-friendly”). Cosmetic and personal care products have been the target of some criticism by its users. Both the cosmetic industry and governments are starting to adapt and take action with the ultimate goal of reducing plastic waste. New ingredient and packaging alternatives are being developed and more sustainable products are starting to appear on the market.

Cannabis-Derived Ingredients in Cosmetic Products

Cannabis-derived ingredients are popular and interesting compounds. There is specific EU and national legislation regarding cannabis-derived ingredients, identifying which extracts and derivatives may be used in cosmetic products. There are several aspects to consider to ensure compliance when adding these compounds to your cosmetics and personal care products.

Cosmetic Claims in the European Union

Claims are an important part of a cosmetic and represent a powerful and essential tool of marketing. It is crucial to know which claims are allowed in cosmetic products in the EU and also how can they be substantiated.

Zinc Pyrithione and its use in Cosmetic Products

Zinc and its salts are often use in the cosmetic industry. Zinc Pyrithione, in particular, is used as an anti-dandruff in rinse-off cosmetic products. But is this ingredient considered safe by the SCCS?

Cosmetic companies obligations under REACH Regulation

REACH is a regulation of the European Union (EU) that stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. All chemical substances manufactured and market in the EU, whether used in our daily lives (e.g. clothes, cleaning products, cosmetics) or industrial processes, are regulated by REACH.

May Butylphenyl Methylpropional be used in my Cosmetic Products?

Butylphenyl Methylpropional, also known as Lilial, is a fragrance ingredient that has been used for years in several cosmetic and non-cosmetic products. Nevertheless, some concerns have been expressed regarding the use of this ingredient and its risk to consumers. The use of Butylphenyl Methylpropional shall be prohibited in cosmetic products from 1st March 2022.

RAPEX System 2020 Report

The rapid alert system (RAPEX) for dangerous non-food products enables national authorities to quickly exchange information about dangerous products. The European Union Safety Gate European RAPEX 2020 annual report was published in March this year. It lists the alerts and follow-up actions taken, per country, product category and risk notified.

Silica – a nanomaterial?

Notification of a cosmetic product containing nano-form ingredients can be complex and involves more costs for the company (cosmetic product owner). The best way to simplify the notification process is to make sure that the Silica and related ingredients used do not fall to the nanomaterial category.

Screening Assessment of Talc by Health Canada

In Canada, Talc was identified as a priority substance for assessment, so the Minister of the Environment and the Minister of Health performed a screening assessment of this compound. Regarding inhalation and perineal exposure, Talc may constitute a potential danger to human life or health.

New Revision of the SCCS Notes of Guidance

The SCCS has issued a new revision of its notes of guidance for the testing of cosmetic ingredients and their safety evaluation. This 11th revision was adopted at its plenary meeting on 30-31 March this year, and it updates the 10th revision that was published in 2018.

Is Propylparaben still considered Safe by the SCCS?

Propylparaben has been assessed several times by the European Commission’s Scientific Committee on Consumer Safety (SCCS). Last year there was a request for scientific opinion concerning the evaluation of a list of ingredients, including Propylparaben. On March, this year (2021), the SCCS issued the requested opinion on this ingredient.


FDA updates on hand sanitizers safety for use

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.

Hand sanitizers contaminated with methanol

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.

Airborne transmission is the dominant route for the spread of COVID-19

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.

Illegal and Ineffective Disinfectants in the EU Market

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.

Could antibody serologic tests downplay SARS-CoV-2 virus prevalence?

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.