News

State of the art of COVID-19 rapid antibody tests

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

EU Intellectual Property rights – are we covered in the UK?

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

Covid-19 IVD Test Kits – Swab Compliance

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

New ISO standard available for COVID Ventilator

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

European standardisation for 2021. An overview of relevant objectives and policies.

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

Allergenic fragrances in cosmetics sold as “perfume-free”: the EDQM report

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 &