The Training on Trends in the Medical Device Industry and Importance of CE Mark
The Training on Trends in the Medical Device Industry and Importance of CE Mark organized by Plastics Institute of Thailand. Mar 5th, 2025 Mandarin Hotel Bangkok
Clinical Evaluation for Medical Devices Training Course
Preamble Clinical evidence plays an important role in the conformity assessment procedure for medical devices. No further approval will be possible in Europe and ASEAN including Thailand without sufficient clinical data to prove the safety, performance and benefit of a medical device. This training will provide you with the basic requirements of the European laws…
UK MEDICAL DEVICE REGULATOR PROPOSES A 12 MONTH DELAY FOR UKCA REQUIREMENTS AND THE NEW MEDICAL DEVICE REGULATIONS
On Friday 21st October 2022, the Medicines and Healthcare Products Regulatory Agency (MHRA) wrote to the medical device industry to explain its intention: To extend the current standstill period by twelve months from July 2023 to July 2024.
Extended IVDR transition period for certain IVD medical devices
The European Union is proposing to delay the go-live date for the incoming medical device regulation pertaining to In Vitro Diagnostics (EU) 2017/746 (IVDR) for products that still need assessment of a notified body, which would allow some manufacturers more time to prepare for compliance to the new Regulation and secure Notified Body support.
UKCA Marking Delay: One Year Extension to the Acceptance of CE Marking in UK
The UK Government has announced an extension to the acceptance of CE marking in the UK until 1 January 2023. This means the businesses will have a further year to start using the UKCA marking for products placed on the Great Britain market, extending the deadline to 1 January 2023.
The European Commission publishes important guidance on the requirements for COVID-19 tests under the IVDD
The Medical Device Coordination Group (MDCG) has published guidance MDCG 2021-21 “Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices” – the document is critical for all manufacturers who manufacture and have CE marked COVID-19 tests under the IVD Directive (IVDD).
Sixth notified body designated under EU IVDR
GMED SAS, which is based in France, has been assigned as the sixth notified body under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR),
The IVDR and performance evaluation studies
The date of application for Regulation (EU) 2017/746 on in vitro diagnostics (IVDR) is approaching quickly. As of May 26, 2022, all manufacturers of IVD medical devices will have to fully comply to the new provisions unless a valid CE certificate issued under IVD Directive (IVDD) is available. The latter scenario will be applicable only…
Guidance document on the impact of genetic variants on SARS-COV-2
The Medical Device Coordination Group (MDCG) has issued a guidance document MDCG 2021-7 for manufactur¬ers of in vitro diagnostic medical devices that relate to SARS-CoV-2.
UK Regulator releases more device registration particulars
The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance giving details impor¬tant for companies registering devices on the UK market.