FAQ

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?

How do I register medical devices in the world

• Marketing in China: what is the Legal Agent responsible for?

• Marketing in Canada: what is the difference between MDAL and MDEL?

• Marketing in Brazil: do I need to get the INMETRO mark?

• What is the 510(k)?