EUDAMED Status Update 2021

The development and deployment of EUDAMED is progressing. Following the implementation plan and getting familiar with the information stored in the database’s modules is crucial for economic operators compliance in the EU market.

EN ISO 13485:2016 – Amendment 11 has been published!

The European standardisation bodies CEN and CENELEC published EN ISO 13485:2016+A11:2021 featuring new annexes ZA and ZB that link the requirements of the MDR (Regulation EU 2017/745) and the IVDR (Regulation EU 2017/746), respectively, to specific clauses of the standard.

New EU Commission Recommendation for PPE and Medical Devices – COVID-19

PPE and Medical Devices have proven to be essential for healthcare workers in the efforts to contain the COVID-19 outbreak. In March 2020, the EU Commission urged the economic operators to increase rapid supply into the market. Currently, the Commission considers that the conditions for exceptional access to market are no longer met, limiting the placing of PPE and Medical Devices which have not successfully undergone the relevant conformity assessment procedures applicable on the EU market.

EU Medical Devices Trade with Switzerland after the Implementation of the MDR

The new EU regulation on medical devices (EU-MDR) has been enforced since May 26, 2021. However, Switzerland is not an EU Member State, which means it is considered a third country according to the new EU-MDR. This entails consequences for the trade of CE-marked medical devices between Switzerland and the EU.

Harmonized Standards for Medical Devices

In July 2021, the European Commission published an Implementing Decision on the harmonized standards for medical devices. These standards were drafted in support of Regulation (EU) 2017/745, the new EU Medical Devices Regulation.

The CORE-MD Project

The new regulation on medical devices (MDR) has already come into force in the EU. The new rules increase clinical evidence requirements for high-risk medical devices. The main goals of the CORE-MD project are to translate expert knowledge into advice for EU regulatory guidance and to strengthen expertise in regulatory science in the clinical community.

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.

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.

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.

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 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.

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.

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 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 – 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.


New Formaldehyde Threshold in Cosmetic Products

The European Commission has issued a draft regulation to amend the preamble of Annex V regarding the threshold for labelling formaldehyde releasers. This amendment results from a scientific advice published by the SCCS concluding that the current threshold does not sufficiently protect consumers sensitized to formaldehyde.

New Restriction on the Use of Benzophenone-3 in Cosmetics

Benzophenone-3 was part of a priority list of potential endocrine disruptors established by the European Commission in 2019. The SCCS was asked to assess the safety of this ingredient and the European Cosmetics Regulation will be amended in accordance with the SCCS assessment conclusions.

endocrine disruptors

European Commission Calls for Data on Ingredients with Potential Endocrine-Disrupting Properties

Substances classified as endocrine disruptors are compounds that can alter the functioning of the endocrine system and negatively affect the health of humans and animals. In 2019, the European Commission set out two lists of ingredients suspected of having endocrine disrupting properties. More recently, the Commission has published a call for data for 10 ingredients that were included in the low priority group (Group B) for the SCCS to be able to assess their safety.

SCCS Preliminary Opinion on Prostaglandins and Prostaglandin-analogues

Following the mandate from the European Commission, the Scientific Committee on Consumer Safety (SCCS) has published a preliminary opinion on Prostaglandins and Prostaglandin-analogues used in cosmetic products. This preliminary opinion is open for comments and the deadline was set for 23 november 2021.

SCCS Preliminary Opinion on Butylated Hydroxytoluene (BHT)

Following the mandate from the European Commission, the Scientific Committee on Consumer Safety (SCCS) has published a preliminary opinion on Butylated Hydroxytoluene (BHT). This preliminary opinion is open for comments and the deadline was set for 23 november 2021.

EU Prohibition of Zinc Pyrithione in Cosmetic Products

Zinc Pyrithione has been used for more than 60 years as an anti-dandruff agent in cosmetic products. Last month, the European Commission published the Commission Regulation (EU) 2021/1092, which includes this ingredient in Annex II. From March 2022 onwards, Zinc Pyrithione will be prohibited in cosmetic products.

EU Chemicals Strategy for Sustainability

The Chemicals Strategy for Sustainability (CSS) was recently published by the European Union. The CSS is part of the European Green Deal which aims for a toxic-free environment leading to zero pollution. The initiative proposes a new legislative amend to the EU Cosmetic Products Regulation. Simplification and digitalization of labelling requirements plus review of the definition of nanomaterial are two of the main objectives of the CSS.

Nanotechnology in Sun Care Products

Nanomaterials are increasingly used in cosmetics and personal care products. They are similar to other chemicals/substances, but with specific risks associated to their use. Currently, there are 4 nano-ingredients approved in the European Union for use as UV filters in cosmetic products.

May Butylphenyl Methylpropional be used in 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. According to an amendment to the CLP Regulation, the use of Butylphenyl Methylpropional will be prohibited in cosmetic products from 1st March 2022.

How are Cosmetic Products Regulated in the United Arab Emirates?

The United Arab Emirates (UAE) are an emerging market for the beauty industry. Cosmetics and personal care products supplied or sold in the UAE must comply with the health and safety requirements set out in UAE legislation. Overall, the process for importing a cosmetic product into the UAE market from the European Union can be quite straightforward since the UAE has aligned several of its requirements with the European Cosmetic Regulation.

European Commission Report on Nanomaterials – 2021

The European Commission is required to submit to the European Parliament and the Council an annual status report on the use of nanomaterials in cosmetic products and to review the provisions concerning nanomaterials in the European Regulation (EC) No 1223/2009 on cosmetic products. In July 2021, the Commission has issued its latest annual report on this subject.

New Labelling Requirements for Cosmetic Products in China

The new Cosmetics Supervision and Administration Regulation (CSAR) was enacted in China. The National Medical Products Administration (NMPA) has released standards for the testing of cosmetic products’ safety profile and efficacy claims. The NMPA has also published the Administrative Measures on Cosmetics Labelling, an updated set of requirements for the label of cosmetic products made available in the Chinese market.

50th Amendment to the IFRA Code of Practice

On June 30, IFRA announced the notification of the 50th Amendment to the IFRA Standards. The Standards form the basis for the globally accepted and recognized risk management system for the safe use of fragrance ingredients and are part of the IFRA Code of Practice. The amendment introduced one update to the Standards and one new prohibited substance – Mintlacton.

How are Cosmetic Products Regulated in India?

The different expectations and needs of consumers are continually changing and therefore the cosmetic industry needs to be gradually evolve to meet the new consumer’s demand. In this regard, India has recently introduced some regulatory updates to ensure that cosmetics placed on the market are safer for all consumers.

Is Phenoxyethanol Safe for Use in All Cosmetic Products?

Phenoxyethanol is a common preservative used in cosmetic and personal care products worldwide. It has been subject to various safety assessments and most concluded about its safety under the current most frequent uses. Nevertheless, some concerns were raised by the French Agency ANSM, particularly regarding its use in products intended for the nappy area in children up to 3 years old.

Cannabis-Derived Ingredients in Cosmetic Products

Cannabis-derived ingredients are popular compounds with interesting properties. 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 cosmetics and personal care products.

Cosmetic Products Testing in the European Union

A cosmetic product which is made available on the European Union market needs to prove that it is safe for consumers. Apart from the mandatory testing, depending on the claims to be used or the type of cosmetic product to be placed on the market, additional tests may be required.

Animal Testing Ban in Mexico

Mexico has become the first country in North America to ban animal testing in cosmetic products. There are now 41 nations in the world that do not allow cosmetics to be tested on animals.

New Amendments to the European Cosmetic Regulation

Commission Regulation (EU) 2021/1099 of 5 July 2021 sets out that Deoxyarbutin should be prohibited in cosmetic products and that the use of Dihydroxyacetone should be restricted in non-oxidative hair dye products and in self-tanning products. This results in one new entry to Annex II and one new entry to Annex III of the European Cosmetic Regulation, respectively.

Fullerenes and Hydroxylated Fullerenes

Fullerenes and Hydroxylated Fullerenes have shown interesting biological activity and have been gaining interest from several fields, including the cosmetic industry. These substances are not regulated under the Cosmetic Regulation (EC) No. 1223/2009. However, there are concerns of potential absorption of nanoparticles with their use in cosmetic products. As such, the SCCS is mandated by the European Commission to assess the safety of Fullerenes and Hydroxylated Fullerenes until the end of 2021.


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.