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.


BREXIT e os Produtos Cosméticos Comercializados em Portugal

No passado dia 22 deste mês, o INFARMED, I.P., emitiu uma Circular Informativa, onde concede um período transitório de 6 meses às empresas, cuja Pessoa Responsável está sediada no Reino Unido e que desejam continuar a ter os seus produtos cosméticos disponíveis no mercado nacional, para que possam enviar toda a documentação e informação necessárias.

Virginia – The Fourth State to Ban Animal Testing in the U.S.

In the United States (U.S.), Virginia is the fourth state to ban animal testing in cosmetic products. The Governor of this state (Ralph Northam) has signed this month (March 2021) a bill and the ban will start on January 1st, 2022. The sale of cosmetics tested on animals will also be prohibited from July 1st, 2022.

France Anti-Waste Law

On February 11th, 2020, the Loi relative à la lute contre le gaspillage et a l’économie circulaire (Anti-Waste for a circular economy) has come officially into force in France. The law provides for a ban on all single-use plastics by 2040.

EU Reduction of the Impact of Certain Plastic Products on the Environment

Cosmetics and personal care industry are a growing business, but with this growth comes a major concern: plastic pollution.
The European Commission has published the Directive (EU) 2019/904, known as Single-Use Plastic Directive. This directive addresses the reduction of the impact of certain plastic products on the environment. Harmonized marking specifications are laid down on the Commission Implementing Regulation (EU) 2020/2151.

Butylphenyl Methylpropional to be prohibited in cosmetics placed in the EU market

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. According to an amendment to the CLP Regulation (Commission Delegated Regulation No. 2020/1182), Butylphenyl Methylpropional is now classified as toxic to reproduction (Repr. 1B – CMR 1B) and it shall be prohibited in cosmetic products from 1st March 2022.

China Bans Microbeads in Cosmetics

On 16th January 2020, China’s National Development and Reform Commission (NDRC) issued the Notice [2020] No. 80, with the aim of prohibiting the use of microbeads in cosmetics and personal care products. More detailed information was given in the Notice [2020] No. 1146, issued by the NDRC on 10th July 2020.

RAPEX System 2019 Report

Every week, the RAPEX system publishes notifications of urgent measures taken by EU Member-States to prevent, restrict or impose conditions on the marketing of products due to the serious and immediate danger they pose to the health and safety of consumers.

Cosmetic Packaging in European Union

Packaging material is defined as the container (or primary packaging) that is in direct contact with the formulation. According to the European Cosmetic Regulation No. 1223/2009, packaging evaluation is mandatory to guarantee cosmetic product safety. To meet this Regulation requirements, the European Commission issued the Decision 2013/674/EU, establishing guidelines on the practical application of such requirements and identifying information that should be collected on the packaging materials and the potential migration of substances from packaging.

“Anti-pollution” claims in cosmetic products

Nowadays, it is possible to find in the market several cosmetic products with claims like “anti-pollution protection”, “pollution shield”, “against pollution damage” and similar ones. But how can a company test and prove this type of allegations?

UK Product Safety and Metrology EU Exit Regulations

The fact that the United Kingdom (UK) has left the European Union (EU) is not news for anyone. This means that the UK will no longer be considered a Member-State of the EU and will be considered a third country, implying that all the EU rules and regulations will no longer apply.

On July 3rd, the UK government has released the last version of the Product Safety and Metrology EU Exit Regulations, which includes the UK Cosmetic Regulation within Schedule 34.

Acetylated Vetiver Oil as a perfuming agent

Acetylated Vetiver Oil, also called Vetiveryl acetate or Vetiveria Zizanioides Root Extract Acetylated, is a natural complex substance derived from Vetiver Oil. In 2019, the European Commission’s Scientific Committee on Consumer Safety (SCCS) issued an opinion on the safety of Acetylated Vetiver Oil in cosmetic products and considered it safe under specific conditions.

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.

Cosmetics Regulation in Australia

Cosmetics and personal care products are regulated in different ways according to the country they are manufactured and made available. Regulatory compliance with international regulations is a critical factor for the internationalization of a cosmetic product. Since 1st July 2020, the Australian Industrial Chemicals Introduction Scheme (AICIS) is the entity responsible for controlling cosmetics. Cosmetic products must be used, advertised and presented in a specific way to be considered cosmetics rather than therapeutic goods.

Ban of animal testing in Australia

Australia’s legislation regarding industrial chemicals has changed. Since July 1st 2020, animal testing information can no longer be used to prove safety of new cosmetic ingredients manufactured in or imported into Australia.

OECD Updated and Corrected Testing Guidelines

The Organisation for Economic Co-operation and Development (OECD) is an international organisation that works on “establishing evidence-based international standards and finding solutions to a range of social, economic and environmental challenges”. The OECD has updated and corrected eight OECD Test Guidelines, in order to continue ensuring chemicals safety and keep up with scientific progress for OECD members and Mutual Acceptance of Data (MAD) adhering countries.

What is Cosmetovigilance?

Essentially, Cosmetovigilance is the continuous compilation, evaluation and monitoring of cosmetic products’ safety, concerning human health. Manufacturers have the responsibility to determine that cosmetic products and their ingredients are safe before they enter the market, as well as to gather reports of adverse reactions.

49th Amendment to the IFRA Code of Practice

The International Fragrance Association (IFRA) was founded in 1973 and represents the interests of the fragrance industry worldwide. The IFRA Code of Practice is essentially the “global fragrance industry’s commitment to promoting the safe use of fragrance for everyone’s enjoyment”. Fragrance compliance means following the rules of the IFRA Code of Practice and the IFRA Standards.

Butylparaben included in ECHA’s SVHC Candidate List

The European Chemicals Agency (ECHA) has updated its Candidate List of Substances of Very High Concern (SVHCs) and included 4 new substances – three that are toxic to reproduction and one endocrine disruptor – Butylparaben, used as preservative in cosmetic products. Now, this list contains 209 substances that may have serious adverse effects on people or the environment.


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.