Latest industry news and developments
Delays in medical device certification in Europe are negatively affecting innovative healthtech and biotech start-ups. There are even opinions that the Medical Device Regulations could lead to an impasse as companies wait for old and new devices to be certified under the new regulations. The confusion is caused by the Medical Device Regulation, which went […]
A simple and accessible format. Clear, understandable language – this is how MDR Regulator’s experts explain even the most complicated issues concerning the medical device industry. With medical device manufacturers and their clients in mind, MDR Regulator together with Pure Clinical have prepared a special educational series, in which experts from both companies explain, among […]
The Clinical Research Center of the Jagiellonian Innovation Center specializes in conducting clinical trials and carrying out complex research and development projects in the field of medicine and related sciences. The center cooperates with leading regional, national and foreign research centers located both in Western Europe and in the USA and Canada. “Our companies operate […]
The conference was a good opportunity to exchange scientific experience in the wide application of natural and synthetic polymers in medicine, pharmacy and dentistry. The meeting was targeted primarily at academics – experienced researchers, as well as students, postgraduates and those working in the field of business practice. The lecture by Katarzyna Romaniszyn entitled: “From […]
Medical products that are sold outside the European Union must undergo conformity assessment procedures that differ from standards in the EU. MDR Regulator, together with its subcontractors, provides expert advice and support in obtaining permits and registrations in foreign markets. As of May 26, 2022, all manufacturers of medical devices and IVDs are treated the […]
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 […]
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.
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.
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.
