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ec logoToday, the EU Commission has published a notice in the OJ that notified bodies might temporarily perform QMS audits remotely in exceptional cases and on a case-by-case basis. Notified bodies can thus deviate from the IVDR and MDR requirement that QMS audits take place on-site.

Member States, notified bodies, industry and other stakeholders have insisted that travel and quarantine restrictions have significantly affected the ability of notified bodies to carry out-site audits at manufacturers' sites. As the inability of notified bodies to carry out on-site audits may increase the risk of a shortage of vital devices, the European Commission responds to requests for exceptional temporary measures, such as remote audits.

The European Commission allows these temporary extraordinary measures given the exceptional and unforeseen circumstances caused by the COVID-19 crisis, the need to ensure continuous access to safe and effective medical devices and medical in vitro diagnostics and the fact that remote audits performed under the Directives seem to show an adequate level of safety.

While reminding the Member States of their obligations to monitor notified bodies established in their territory, this notice gives them the possibility to allow notified bodies to carry out remote audits on a temporary basis. Notified bodies are required to identify and justify remote audits on a case-by-case basis, and the individual circumstances should be documented and duly substantiated. Member States are invited to inform the EU Commission of measures taken by individual notified bodies (including information to justify such measures).

We advise you to discuss your options for a remote audit with your notified body as soon as possible and use the already available MDCG documents (MDCG 2020-4 and MDCG 2020-17) on remote audits to prepare accordingly. A remote audit requires thorough preparation; this includes:

  • Scheduling mock remote audits;
  • Testing the connection and sound quality beforehand;
  • Ensuring that all audit participants are familiar with the required hard- and software;
  • Clarifying legal aspects in advance (consider data security and privacy issues in connection with sharing of documents, recordings, use of the camera, etc.);
  • If employees participate from their home office: ensuring that the connection, infrastructure etc. are sufficient;
  • Ensuring the IT department is ready to deal with possible technical problems (e.g. connection issues).

If you have questions regarding audit preparation (remote or on-site), our team of experts is always ready to help.

ISS AG, Integrated Scientific Services AG, participated to the 12th Global Entrepreneurship Week. With numerous events organised in 180 countries, the Global Entrepreneurship Week sets out to celebrate entrepreneurship and innovation.

The Campus Biotech Innovation Park and Geneus celebrated this event in the heart of Geneva in the form of a Café & Croissant including a virtual tour of the premises and short videos of the companies contributing to this ecosystem. The video recorded from the ISS AG Geneva-based office is here.

How ISS AG can support innovation? Please, read our offer for the Newcomers in Medtech.

Guest Lecture by H. Riedwyl on Apps & Medical Device Software, October 21, 2020 at the Center for Digital Health Interventions  of ETHZ and Uni SG.

Participation is free.

More information including the link to the Zoom-Meeting you find here.

20201005 Flyer ILMAC 2020

BioAlps and ISS AG, Integrated Scientific Service in collaboration with the Swiss Biotech Association and the Swiss Chemical Society organise a Medtech symposium on Thursday 8 October to provide information to Medtech companies regarding the CE-marking process, specifically within the new EU MDR which has been postponed to May 2021 due to Covid-19.

In the form of a round-table, punctuated by each topic flash introduction to bring everybody on the same floor, Swiss Industry experts will share their experience and recommendation to cope with the new requirements and timelines. Among other topics, the challenges regarding the establishment of a product registration strategy in such a context, the business impact of MDR, the lack of qualified resources and the generation of clinical data will be addressed at the round-table.

The event is announced here.

Free registration and more general information, including covid protection concept: www.ilmac.ch.

Thank you very much for your participation to the session on “Artificial Intelligence & Medtech” lead by Hansjörg Riedwyl as well as for visiting our stand and the interesting discussions raised towards the development, registration and maintenance on the market of embedded medical device software and software as a medical device.

More info on our services in this field here: ISS AG – Medical SW Development

Other ISS AG services, including the CRO for your clinical data acquisition according to the latest applicable requirements: ISS AG – Medtech Services

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