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.
Liliana Teles

Liliana Teles

Regulatory Affairs Manager

EUDAMED is the European Databank on Medical Devices which came into force in May 2011. EUDAMED was created as a central repository for information on market surveillance exchanged between national competent authorities and the European Commission, with the purpose of strengthening surveillance and transparency with regards to medical devices placed on the European market.

The new regulations on medical devices (MDR) and on in vitro diagnostic medical devices (IVDR) establish a much wider EUDAMED database than the existing one under the current European Directives.

Updates continue to be issued from the European Commission concerning EUDAMED in light of the current COVID-19 pandemic.

The EUDAMED launch has been postponed with a two-year delay compared to initial expectation, until May 2022. However, the European Commission has announced that some modules of EUDAMED will be made available to users before the official EUDAMED date of application in May 2022. Hence, it becomes possible for economic operators to start using EUDAMED before May 2022.

At present, the European Commission has the following implementation plan:

2021 March: the Actor Registration Module will become available. This module will allow for manufacturers, authorized representatives, importers as well as systems and procedure pack producers to enter their data in EUDAMED and to acquire a Single Registration Number (SRN) for declarations of conformity and certificates.

2021 May (expected): the UDI/Device Registration Module and the Certificates and Notified Bodies Modules will be made available (after the Actor module, as soon as functional). At this time, it is anticipated that manufacturers will be able to begin submitting UDI information to EUDAMED.

2022 May: EUDAMED Launch (all modules complete and released, e.g., clinical investigations, incident reporting and market surveillance will become available afterwards as soon as they are functional).

2022 May – 2023 Nov: EUDAMED Device Registration period of 18 months for Legacy, MDR, and IVDR devices.

References:

1. European Commission – European database on medical devices (EUDAMED) – https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/eudamed_en

further
reading

cosmetic products

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.

Read More »
cosmetic products

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.

Read More »
endocrine disruptors
cosmetic products

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.

Read More »
cosmetic products

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.

Read More »
cosmetic products

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.

Read More »
cosmetic products

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.

Read More »
medical devices

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.

Read More »
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.

Read More »
cosmetic products

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.

Read More »
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.

Read More »
cosmetic products

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.

Read More »