FAQ

EN

FAQ

Frequently Asked Questions

Below you'll find answers to the questions we get asked the most about Market Access Europe for Medical Devices and IVDs but also about FDA, NMPA and Global market access. If you have a question for one of our experts, send a mail to FAQfriday@@qservegroup.com.

FAQ Friday with Coenraad Davidsdochter: answer to your questions regarding Risk Management

🔎 In this weeks FAQ Friday, Coenraad Davidsdochter answers questions regarding Risk Management

FAQ Friday In-Vitro Diagnostics IVDR Risk Management

FAQ Friday with Stefan Menzl: answers to your questions regarding Swiss Authorized Representative

🔎 In this weeks FAQ Friday, Stefan answers questions regarding Swiss Authorized Representative

European Authorized Representative FAQ Friday MDR 2017/745

FAQ Friday with Danielle Motta: answer to your question regarding the MHRA database

🔎 In this weeks FAQ Friday, Danielle answers the question: will the MHRA database be open to the public?

FAQ Friday MHRA

February 05, 2021

FAQ Friday with Amé Huige: answers to your questions regarding UK registration for custom-made devices

In this weeks vlog, Amé answers questions regarding UK registration for custom-made devices

Brexit FAQ Friday Labelling MHRA UK Responsible Person

January 22, 2021

FAQ Friday with Giovanni: answers to your questions about vigilance and incident reporting

In this weeks vlog, Giovanni answers the question: Does it mean that if a certain type of serious incident has been listed in the IFU and assessed in the risk management as acceptable, then it is not to be reported? Even if it has a causal relationship with the device?

FAQ Friday MDR 2017/745 Medical Device Regulations Vigilance Highlights

January 08, 2021

FAQ Friday with Amé Huige: answers to your questions about EUDAMED training

In this weeks vlog, Amé answers your questions about training on EUDAMED

EUDAMED FAQ FAQ Friday Training

December 18, 2020

FAQ Friday Special Edition with Páll Jóhannesson: answers to your questions regarding PMCF Surveys

This week's FAQ Friday we are teaming up with Páll Jóhannesson from SMART-TRIAL because who knows more about surveys than Páll?

EDC FAQ Friday PMCF Post Market Clinical Follow-up Surveys

December 11, 2020

FAQ Friday with Stefan Menzl: answers to your questions about importer labelling and PMCF surveys

In this weeks vlog, Stefan answers questions regarding importer labelling and PMCF surveys

FAQ Friday Labelling PMCF Post Market Clinical Follow-up

December 04, 2020

FAQ Friday with Henk-Willem Mutsaers: answers to your questions about common area/topics that are misses from MDR internal audits

In this weeks vlog, Henk-Willem answers questions about common area/topics that are misses from MDR internal audits

Audit program Auditing FAQ Friday Medical Device Regulations

November 27, 2020

FAQ Friday with Sue Spencer: answers to your questions about IVDR Classification Guidance | part 2

In this weeks vlog, Sue Spencer guides you through the IVDR Classification guidance.

Classification Rules FAQ Friday Guidance IVDR

November 20, 2020

FAQ Friday with Sue Spencer: answers to your questions about IVDR Classification Guidance | part 1

In this weeks vlog, Sue Spencer guides you through the IVDR Classification guidance.

Classification Rules FAQ Friday Guidance In-Vitro Diagnostics IVDR

November 13, 2020

FAQ Friday with Gert Bos, answers to your questions regarding residual risks

In this weeks vlog, Gert Bos answers questions regarding residual risks.

FAQ Friday GSPR Residual Risks

November 06, 2020

FAQ Friday with Wiebe Postma: answers to your questions about PMCF, class l devices and Article 61(10)

In this weeks vlog Wiebe Postma answers your questions about PMCF, class l devices and Article 61(10)

FAQ Friday PMCF PMS Post Market Clinical Follow-up Post Market Surveillance

October 30, 2020

FAQ Friday with Stefan Menzl: answers to your questions about changes to MDD devices

In this weeks vlog Stefan Menzl answers to your questions about changes to MDD devices

FAQ Friday MDD 93/42/EEC MDR 2017/745 Medical Device Directive Medical Device Regulations

October 23, 2020

FAQ Friday with Max van Regteren: answers to your questions about European Authorized Representatives (EAR)

What is a European Authorized Representative? Why do you need one? What are their responsibilities and can I sell my medical devices all over Europe once I have a European Authorized Representative? 🔎 This week's FAQ Friday, Max van Regteren will answer all above questions!

EAR European Authorized Representative FAQ Friday

October 16, 2020

FAQ Friday with Jan-Paul van Loon: answers to your questions about 3D printing

In this weeks vlog, Jan-Paul van Loon answers to your questions about 3D printing

3D printing Custom-made devices FAQ Friday Medical Device Regulations

October 09, 2020

FAQ Friday Special Edition with Bassil Akra: answers to your questions about Notified Bodies

This week's FAQ Friday we are teaming up with Bassil Akra from QUNIQUE because who knows more about Notified Bodies than Bassil?

FAQ Friday Medical Device Regulations Notified Body Regulatory Affairs

October 02, 2020

FAQ Friday with Jan van Lochem: answers to your questions about clinical data for existing devices

In this weeks vlog, Jan van Lochem answers to your questions about clinical data for existing devices

Clinical Data FAQ Friday PMCF

September 25, 2020

FAQ Friday with Sue Spencer: answers to your questions about MHRA Brexit Guidance | part 2

In this weeks vlog, Sue Spencer guides you through the MHRA BREXIT guidance.

Brexit FAQ Friday Guidance MHRA

September 18, 2020

FAQ Friday with Sue Spencer: answers to your questions about MHRA Brexit Guidance | part 1

In this weeks vlog, Sue Spencer guides you through the MHRA BREXIT guidance.

Brexit FAQ Friday Guidance MHRA

September 11, 2020

FAQ Friday Special Edition with Erik Vollebregt: answers to your question about legal representation

This week's FAQ Friday we are teaming up with Erik Vollebregt from Axon Lawyers because who knows more about legal representation than Erik?

Legal representation FAQ Friday Regulatory Affairs

September 04, 2020

FAQ Friday: Answers to your questions about confidentiality during remote audits

In this weeks vlog, Henk-Willem Mutsaers answers the question: how are new confidentiality and security concerns being addressed in remote audits?

Audit program Auditing FAQ Friday Regulatory Affairs

August 28, 2020

FAQ Friday: Answers to your questions about China legal agent

In this weeks vlog, Michael Yan answers the question: what are the requirements of China Legal Agent (or China Authorized Representative)? And what are their rights and obligations?

China China Agent FAQ FAQ Friday Regulatory Affairs

August 21, 2020

FAQ Friday: Answers to your questions about remote audits after COVID

In this weeks FAQ Friday vlog, Henk-Willem Mutsaers answers questions about remote audits after COVID-19

Auditing FAQ Friday

August 07, 2020

FAQ Friday: Answers to your questions about PMCF and PSURs

In this weeks FAQ Friday vlog, Giovanni di Rienzo answers questions about PMCF and PSURs.

FAQ Friday PMCF

Stay up to date with the latest updates from Qserve