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Latest industry news and developments

May 12, 2023

MDR Regulator at Impact ’23

The two-day session included a panel entitled: “Diagnostic potential using new technologies/ Diagnostic potential using new technologies,” moderated by Katarzyna Wesołowska, CEO of MDR Regulator Sp. z o. o. and Board Member of Pure Clinical Sp. z o. o. The debate was attended by Piotr Węcławik, Director of Innovation at the Ministry of Health, Rafał […]

May 26, 2021

26 May 2021 – MDR is fully applicable today!

On 26 May 2021, the MDR has been fully applicable, following the transition period. If you are a Manufacturer, Importer or Distributor of medical devices, or have other responsibilities under the MDR, please make absolutely sure that you are a 100% ready for new obligations.

March 26, 2021

MDR requirements for custom-made medical devices

The Medical Devices Coordination Group (MDCG) established under Article 103 of Regulation (EU) 2017/745 published in March 2021 recommendations regarding the qualification of adaptable mass-produced medical devices, custom-made devices (CMD) and their components.

January 18, 2021

How BREXIT affects the export of medical devices to the UK?

From 1 January 2021, the United Kingdom is out of the customs union ,the single market of the European Union and ceased to be bound by EU law. Until the last few days, it was unclear how the UK's cooperation with the rest of the European Union would ultimately look. The Brexit deal creates regulatory barriers to trade in medical devices between the UK and the European Union.

July 24, 2020

MDR postponed for a year – how to plan the implementation stategy?

Regulation of the European Commission No. 745/2017 (MDR) significantly changed the requirements set out in the current Directives 93/42 / EEC and 90/985 / EEC was prepared for many years. After long expectations, in 2012 the first proposal for a Regulation was presented, which is much more restrictive than the applicable law. Therefore, many significant comments and proposals for the Regulation were made, so it lasted up to 5 years to publish the final version. Therefore it is not surprising, that companies and organizations in the medical industry have been worried by the fact about short implementation period of the new law.

May 25, 2020

Personal protection medical devices on the EU market during COVID-19 pandemic

COVID-19 disease, caused by coronavirus, is primarily transmitted by droplet infection through contact with infected persons. When an infected person coughs, sneezes or talks, small airborne particles are transferred to another person. There is currently a very high demand for protective equipment designed to provide protection against airborne particles, including protective masks, medical gloves, overalls and face shields. These items of personal protective equipment, which are used primarily to protect the health of medical professionals and infected persons in health care facilities, are classified as medical devices. The most important aspects to consider when placing new personal protection medical devices on the market are presented below.

April 27, 2020

Repackaging of a medical device or translated its labelling

The purpose of this article is to address the interpretation of the provisions in Article 16 of EU Regulation 2017/745. Recently, misinterpretations of the regulations contained in that Article have been voiced at medical device conferences. Our analysis and its outcome are consistent with the interpretation advocated by 27 notified bodies in the area of medical devices that take part in regular meetings of the Notified Body Group. It is not by chance the fact that those meetings are also attended by representatives of the European Commission.

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