Thanks to Swedish Medtech Regulatory Summit

Last week we were present at the Swedish Medtech Regulatory Summit. A big thank you to Swedish Medtech for a great event and thank you to all of you visiting our both on site and digital as well as listening to Cecilia Emanuelsson and Cilla Lundevall. If you would like to know more or if you have further questions don’t hesitate to contact us at info@qadvis.com. You can also sign up to get information on news, courses and free seminars here or follow us at LinkedIn.

 

… with BSI regarding MDR-Application Process

MDR Application Process – What do you need to know?
QAdvis have invited Magnus Olla from BSI in Sweden to give us some “need-to-know” when you plan for your MDR-Application. Magnus will also talk a about the new regulation 2023/607 amending regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices.

Speaker: Magnus Olla is Business Development Manager at BSI and have a broad experience within the medical device area and have working at different Notified Bodies

Date/Time: 2023-04-25 Presentation starts at 14.00 – 15.00 including Q&A

Welcome to a pre-chat with coffee and cake (get some Swedish fika) from 13.30, meet our speaker and mingle with other industry colleagues.

Location: Medicon Village, Byggnad Inspira Ground Floor. LOKAL: Sharience. Scheeletorget 223 63 Lund

Note: The event is free but space is limited. If you are not able to participate, we urge you to make a cancelation as soon as possible or assign your place to a colleague. If you register but don’t attend, you will be charged 200 SEK.

Register here at Evenbrite

Extension of the MDR transitional period and removal of the “sell off” periods

European commission has now official published the Q&A on practical aspects related to the implementation of regulation 2023/607 amending regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. 

The amendment of the MDR and of the IVDR through Regulation (EU) 2023/607 aims to ensure a high level of public health protection, including patient safety and an avoidance of shortages of medical devices needed for the smooth functioning of healthcare services, without lowering current quality or safety requirements. For that purpose, manufacturers and notified bodies are given sufficiently more time to carry out, in accordance with the MDR, the conformity assessment of devices covered by a certificate or a declaration of conformity issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC. Moreover, the deletion of the ‘sell off’ date in the MDR and the IVDR aims to prevent unnecessary disposal of safe devices.

The answers to the questions set out in the document have been developed by taking into account the objectives pursued by the amendment with a view to making best use of the additional time provided by the extension of the MDR transitional period.

Read more about it here: https://health.ec.europa.eu/medical-devices-sector/new-regulations_en

 

If you would like to know more or need someone to discuss this further with,
don’t hesitate to contact Annelie Hagström here.

 

Come and Meet Us at the Regulatory Summit on March 30th

We are present at Swedish Medtech’s Regulatory Summit on March 30th. Meet us here if you want to know more about what we do, or if you just want to have a quality and regulatory chat. And take the chance to listen to two of our most experienced consultants, Cecilia Emanuelsson and Cilla Lundevall.