FAQ

FAQufficiomarketing2022-07-27T07:38:52+02:00

Swiss – Exit: Requirements for marketing Medical Devices in Switzerland

Swiss Exit: what requirements should EU Manufacturers of Medical Devices satisfy now?

Why is Switzerland considered a Third Country by Europe?

For which Medical Devices is it necessary to appoint a Swiss Authorised Representative?

Do Swiss Authorised Representative and Importers of Medical Devices have to register in EUDAMED?

IVDR (EU) 2017/746

Transitional period: can in vitro Diagnostic Medical Devices, conform to the current IVDD, be placed on the EU market after May 26, 2022?

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?

How does the Regulation on in Vitro Diagnostic Medical Devices (IVDR) affect the Quality Management System?

When do Manufacturers of in vitro diagnostic Medical Devices have to conform to the IVDR (EU) 2017/746?

What is the in vitro diagnostic Medical Devices regulation IVDR (EU) 2017/746? When does it apply?

What will be the impact of MDR (EU) 2017/745 on EC MDD certificates in ‘period of grace’?

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?

What are the MDR requirements for post-market surveillance, market surveillance and vigilance?

What is the “post-market surveillance system”?

How can I continue to sell my devices after the full implementation of MDR?

 

How to register radiation-emitting Medical Devices with CDRH

What is the Accession Number?

Which Medical Devices are classified as electronic products that emit radiation?

What does the CDRH do?

Why CE marking is necessary

How will the IVDR 2017/746 affect the Quality System Management?

What does the entry into force of IVDR 2017/746 entail for manufacturers of in vitro diagnostic Medical Devices?

When will the IVDR 2017/746 enter into force?

When is the Notified Body’s intervention needed?

When do I have to appoint an Authorized Representative?

How can I establish a medical device risk class ?

What is the OBL contract?

What is a regulatory strategy

How do I select the country where I want to sell my devices?

How do I find the information I need to sell my devices?

What are GMP requirements

What is MDSAP?

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 ?

Marketing in Canada: what are the disclosure obligations required by Directive SOR 98-282?

GMP FDA: which production processes should I validate?

How to register Medical Devices in the world

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)?

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