Blog

New service – Authorized Representative (CH-REP, Swiss AR) in the Swiss market

Medical products that are sold outside the European Union must undergo conformity assessment procedures that differ from standards in the EU. MDR Regu...

Katarzyna Romaniszyn Head of Regulatory and Quality Management Department

MDR Regulator at Impact ’23

The two-day session included a panel entitled: “Diagnostic potential using new technologies/ Diagnostic potential using new technologies,”...

Katarzyna Wesołowska Vice President of the Board

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 devi...

Katarzyna Wesołowska Vice President of the Board

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 regard...

Adrianna Pyrzanowska Regulatory Affairs Associate

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 o...

Adrianna Pyrzanowska Regulatory Affairs Associate