The document MDCG 2025-5 has been released by the Medical Device Coordination Group (MDCG) on 18 June 2025, aiming to provide questions and answers regarding performance studies of in vitro diagnos...

The document MDCG 2025-5 has been released by the Medical Device Coordination Group (MDCG) on 18 June 2025, aiming to provide questions and answers regarding performance studies of in vitro diagnos...

European Commission released the 12th notified bodies survey on certifications and applications (MDR/IVDR) (with data status 31 October 2024) on 8 May 2025.

Team-NB members adopted a common paper aimed at describing in detail the pre-application, application and post application phases processes through which manufacturers may apply to Notified Bodies ...

The European Commission has implemented Regulation (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices.

MedTech Europe released a report on Administrative Burden under IVDR and MDR, aiming to map out the main areas of administrative burden under IVDR/MDR which could be considered unnecessary and iden...

Team-NB set up a new ½ day training for manufacturers dedicated to clinical aspects. The training is planned on May 7th morning.

European Commission released a draft amendment to Regulation (EU) 2021/2226 on 21 February 2025, updating the rules as regards electronic instructions for use.

MedTech Europe shares the results of its 2024 Regulatory Survey, highlighting challenges manufacturers face with the In Vitro Diagnostic Regulation and Medical Device Regulation on 15 January 2025.

The basic terms and definitions of the UDI system will be elaborated for further understanding and better use.

The document MDCG 2022-3 Rev.1 has been released by the Medical Device Coordination Group (MDCG) on 18 December 2024, aiming to provide guidance to notified bodies to clarify their role and respons...

Team-NB members adopted a common paper aimed at describing in detail the pre-application, application and post application phases processes through which manufacturers may apply to Notified Bodies ...

PYQ Lab has successfully passed IAS scope extension review in compliance with ISO/IEC Standard 17025, and is accredited to provide the services specified in the scope of accreditation.

European Commission released the 10th notified bodies survey on certifications and applications (MDR/IVDR) (with data status 30 June 2024) on 30 October 2024.

The document MDCG 2021-4 Rev.1 has been released by the Medical Device Coordination Group (MDCG) on 25 September 2024.

Regulation (EU) 2024/1860 has been published in the Official Journal of the European Union on 9 July 2024.

PYQ Lab has successfully obtained the Biosafety Laboratory Record Certificate (BSL-2) issued by Suzhou Municipal Health Commission.

The Council of European Union has adopted new rules updating the law on medical devices, including in-vitro diagnostic medical devices (IVDs) on 30 May 2024.

PYQ Lab has got IAS accreditation certificate, satisfying IAS accreditation requirements in compliance with ISO/IEC Standard 17025, and was granted permission to use IAS Mark and ILAC MRA Mark.

European Commission released the 8th notified bodies survey on certifications and applications (MDR/IVDR) (with data status 29 February 2024) on 17 May 2024.

PYQ Lab, a cutting-edge In-Vitro Diagnostic (IVD) testing facility under the investment worth CYN 50 million from IMQ and PureGlobal, was established in 2023 within the Suzhou Industrial Park.