Latest industry news and developments

August 9, 2021

How to properly label a medical device according to the MDR (2017/745)?

With the entry into force of the Regulation 2017/745, new labeling requirements for medical devices have been implemented, and described in detail in Annex I to the MDR, specifying the general safety and performance requirements. In July this year, an update of the EN ISO 15223-1 standard was published concerning the symbols and information provided on the labels of medical devices.

Adrianna Pyrzanowska,   Medical Devices Consultant
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.

Katarzyna Wesołowska,   President of the Board
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.

Adrianna Pyrzanowska,   Medical Devices Consultant
January 20, 2021

MDR and MDD Differences – what is going to change in May 2021

The new MDR Regulation (745/2017) compared to the current MDD (93/42/EEC) and AIMD (90/385/EEC) is much more extensive and detailed - it contains 123 articles and 17 annexes - which is more than 175 pages in total, compared to the 60-page Directive.

Katarzyna Wesołowska,   President of the Board
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.

Katarzyna Wesołowska,   President of the Board
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.

Adrianna Pyrzanowska,   Medical Devices Consultant
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.

Adrianna Pyrzanowska,   Medical Devices Consultant
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.

Adrianna Pyrzanowska,   Medical Devices Consultant