Blog

Delays in medical device certification and innovative healthtech and biotech start-ups

Delays in medical device certification in Europe are negatively affecting innovative healthtech and biotech start-ups.  There are even opinions that t...

Katarzyna Wesołowska Board Member

Holiday educational series a joint initiative of MDR Regulator and Pure Clinical

A simple and accessible format. Clear, understandable language – this is how MDR Regulator’s experts explain even the most complicated iss...

Katarzyna Romaniszyn Head of Regulatory and Quality Management Department

MDR Regulator and Pure Clinical have established cooperation with the Clinical Research Center of the Jagiellonian Innovation Center

The Clinical Research Center of the Jagiellonian Innovation Center specializes in conducting clinical trials and carrying out complex research and dev...

Katarzyna Wesołowska Board Member

The 4th National Scientific Conference – Polymers in Medicine is behind us

The conference was a good opportunity to exchange scientific experience in the wide application of natural and synthetic polymers in medicine, pharmac...

Katarzyna Romaniszyn Head of Regulatory and Quality Management Department

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 Board Member

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 Board Member

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