The IVDD requires from manufacturers to design and manufacture devices in such a way that they are suitable for the intended purpose, taking into account the generally acknowledged state of the art. The manufacturer should therefore justify why the device is suitable for the claimed intended purpose, in light of
The French Competent Authority (ANSM) has prohibited the sale of antibody self-tests based on urine specimen, in view of its inefficacy and non-conformity with the EU requirements, i.e. because their manufacturers have not obtained a CE Certificate issued by a Notified Body. Moreover, the disputed urines tests were made
Following the Health Security Committee’s Recommendations on a common framework for the use and validation of rapid antigen test and the mutual recognition of COVID-19 test results, on January 2021, the Member States unanimously decided to settle a common framework covering the utilization of rapid antigen tests and the
From January 1, 2021, all EU Trade Marks (EUTM), Registered Community Designs (RCDs) and International Registrations designating will no longer provide protection in the United Kingdom. Based on the Withdrawal Agreement, the IPO will create a re-registered UK design for every Registered Community design (RCD) and International design (EU) and
Directive 98/79/EC on in-vitro diagnostic medical devices (IVDD) currently applies to Covid-19 tests. In order to place this type of tests on the EU market, compliance with the relevant provisions of the Directive is necessary (European Commission, 2020). Special attention needs to be paid when Covid-19 tests include
Manufacturers of medical devices, IVDS, and cosmetics, are you aware of the new UK requirements and approaching deadlines? Cosmetics New products placed on the Great Britain (GB) market as of 1 January 2021 must be notified on SCPN prior to being placed on the market. The information that has to
The COVID-19 pandemic has provoked a great impact, especially for medical devices, and there has been a much necessary adaptation effort. In this respect, the International Standards Organization (ISO) has announced the elaboration of new standards on Ventilators and Pulse Oximeters. The new ISO/DIS 80601-2-90 standard - currently under
At the end of 2020, the European Commission (EC) released a Notice regarding the Annual Union Work Programme for European Standardisation for 2021 in accordance with article 8 of the European Standardisation Regulation. As a prime concern, the 2021 programme targets the improvement of European standards on behalf of the
Between 2018 and 2019, the European Network of Official Cosmetics Control Laboratories (OCCLS) conducted a survey on cosmetics’ compliance with label and claim requirements, in particular the ones concerning allergenic fragrances. The related report was published on December 15, 2020 by the European Directorate for the Quality of Medicines &
On December 11, 2020 the EU Commission adopted two Directives – 2020/2088 and 2020/2089 – to amend the Annex II to the Toy Safety Directive (2009/48/EC). The said Annex concerns particular safety requirements. In Part III point 11, it provides: A list of allergenic fragrances that shall not
Following the EU Commission’s proposal of December 18, 2020, the Council of the European Union adopted on January 21, 2021 a Recommendation on a common framework for the use and validation of rapid antigen tests and the mutual recognition of COVID-19 test results in the EU. The Recommendation is
Legislative Framework The Single-Use Plastic Directive (EU) 2019/904 was published in June 2019. Also known as SUP Directive, this law aims to prevent and reduce the impact of certain products containing plastic on the environment, specifically the marine environment, and on human health. The measures listed within this Directive
