IVDR (EU) 2017/746
When do Manufacturers of in vitro diagnostic medical devices have to conform to the IVDR (EU) 2017/746?
What is the “sell off” provision?
Is it possible to self-certificate devices in the field of the Regulation on in Vitro Diagnostic Medical Devices IVDR (EU) 2017/746?
What are the main changes provided for in the Regulation on in Vitro Diagnostic Medical Devices IVDR (EU) 2017/746?
What is the in vitro diagnostic medical devices regulation IVDR (EU) 2017/746? When does it apply?
Transitional period: can in vitro diagnostic medical devices, conform to the current IVDD, be placed on the EU market after May 26, 2022?
How does the Regulation on in Vitro Diagnostic Medical Devices (IVDR) affect the Quality Management System?
MDR (EU) 2017/745 impact on CE MDD certificates during the “period of grace”
How can I continue to sell my devices after the full implementation of MDR?
What is the “post-market surveillance system”?
What are the MDR requirements for post-market surveillance, market surveillance and vigilance?
What is the “period of grace” and how can I take advantage of it?
What is the difference between market surveillance, post-market surveillance (PMS) and vigilance?
How to register radiation emitting medical devices with the CDRH
What does the CDRH do?
Which medical devices are classified as electronic products that emit radiation?
What is the Accession Number?
What is the Product (Initial) Report to the CDRH?
Why is the CE marking required
What does the entry into force of IVDR 2017/746 entail for manufacturers of in vitro diagnostic medical devices?
What is the OBL contract?
How can I establish a medical device risk class ?
When is the Notified Body’s intervention needed?
When do I have to appoint an Authorized Representative?
How will the IVDR 2017/746 affect the Quality System Management?
What are the main changes compared to the previous Directive 98/79/EC?
When will the IVDR 2017/746 enter into force?
What is a regulatory strategy
How do I find the information I need to sell my devices?
How do I select the country where I want to sell my devices?
What are the GMP requirements
Marketing in Canada: what are the disclosure obligations required by Directive SOR 98-282?
cGMp FDA: when can I exclude the design from my quality system according to the US cGMP?
How many reviews should I expect during the device design ?
What is MDSAP?
GMP FDA: which production processes should I validate?