QA Regulatory forum: Classification and Risk assessment according to MDR

Connected Care/Digital Health — Digital health — Medical device —
05 April
08:00 - 10:00

Medical Growth House - Forskningsparken
Social Zone

In May 2017, the European Parliament published a set of regulations for medical devices (MDR) and in-vitro diagnostics (IVDR) that will require companies to make significant changes to their manufacturing, clinical investigation, quality assurance and data reporting processes.

The new medical device regulations (MDR) and IVD regulations (IVDR) were largely driven by the need to safeguard patient safety in response to technological progress. As medical devices and IVDs become increasingly advanced and therefore complex, there is usually a higher risk to the patient. An important aspect of the new regulations aims to tackle this issue by redefining and reclassifying medical devices and IVDs. This will tighten regulations around devices that could pose risk to the human body. The majority of changes apply to IVDs, although there are some noteworthy changes with medical devices.

As a producer of health technology you need to know what the changes entail.

We would like to invite you to a breakfast meeting to learn more about this.

Program:

08:00 – Light breakfast and mingling

08:30 – Welcome by Anita Moe Larsen, Norway Health Tech

08:35 – The expert’s view by Therese Albinsson, MedQtech

08:55 – The authorizing party’s view by Legemiddelverket, Ingeborg Hagerup-Jenssenseniorrådgiver, medisinsk utstyr

09:20 – Discussion between the two presenters – audience is welcome to ask questions

09:40 – Wrap-up and thank you for coming!

You will be able to book 1:1 meetings with MedQtech after the workshop if you’d like. Just send an e-mail!

WELCOME!

Register

Documents and presentations

Introduction to Norway Health Tech

by Anita Moe Larsen

The Experts view

by Therese Albinsson, MedQtech

From the authorities point of view

by Ingeborg Hagerup-Jenssen, Legemiddelverket