Provides you with access to the most relevant documents, guidances and whitepapers relevant to your daily work in the area of medical devices and in vitro diagnostic medical devices.
QMD Services regularly publishes specific white papers on current issues and regulatory topics. To access the white paper, simply click on the desired document and proceed with the download. We hope you enjoy reading it!
Expert Sessions, Anytime
Please find below a link to our latest webinars, which are available to view at your convenience. These webinars explore emerging trends, challenges and solutions in an accessible format. Each session will share real-world experience and professional know-how to help you stay ahead in the regulatory landscape. This expert knowledge is available to you free of charge.
Presenter: Mark Varney
Language: English
Length: 20 min
Our webinar on MDR Article 16 clearly explains the obligations companies face when providing, modifying, or translating medical devices. Learn through practical examples how to ensure compliance and avoid common mistakes. Perfect for professionals who want to gain targeted and efficient insights.
Presenter: Mark Varney
Language: English
Length: 14 min
Our webinar on MDS Code 1014 for combination devices provides a clear overview of regulatory requirements under both MDR and IVDR. Learn how to correctly classify and manage combination products while ensuring full compliance across both regulations. This session highlights our unique expertise as an organization certified under MDR and IVDR. Ideal for professionals seeking reliable, practical guidance.
Presenter: QMD and UL Solutions
Language: English
Length: 1 h
Our webinar on IVD legacy devices transition period timelines and requirements provides a clear overview of the regulatory deadlines and key obligations under the IVDR. Learn what manufacturers must consider during the transition phase, how to maintain market access, and how to avoid compliance gaps.
Presenter: Elizma Parry
Language: English
Length: 30 min
Our webinar on Article 117 covers the requirements for obtaining a Notified Body Opinion for drug-device combination products under the MDR. Learn how to navigate the interface between medicinal product and medical device regulations, understand the expectations for technical documentation, and avoid common pitfalls in the submission process.
Presenter: Mark Varney
Language: English
Length: 1h
Here you will find valuable supplementary information that is made available to the public (e.g., the currently valid version of the EU Regulations IVDR and MDR, guidance documents, standards, and frameworks).
This public information can assist you in successfully completing your application process.
Regulation (EU) 2017/745 (MDR)
Link to the Medical Device Regulation in your language
Regulation (EU) 2017/746 (IVDR)
Link to the in vitro diagnostic devices Regulation in your language
Regulation (EU) 2017/745 (MDR)
Link to the Medical Device Regulation in your language
Regulation (EU) 2017/746 (IVDR)
Link to the in-vitro-diagnostics Regulation in your language
MDCG
Up to date medical device guidance documents of the European Commission
(MDCG)
ISO
Link to International Organization for Standardization (ISO)
CEN/CENELEC
Link to European and European Electrotechnical Committee for Standardization
NANDO
Link to New Approach Notified and Designated Organisations (NANDO) Information System
European Commission Expert Panels
Link to the European Commission Expert Panels (CECP/PECP)
Fill out the form below, and a download link to the “MDR Article 16 – What Does It Mean For Importers and Distributors of Medical Devices”
will be send to you via email.
Fill out the form, and a download link to the “IVD Legacy Devices” will be send to you via email.
Fill out the form below, and a download link to the “Medical Devices incorporating IVD Components – MDR code MDS 1014”
will be send to you via email.
Fill out the form, and a download link to the “QMD and MDR Article 117 Drug-Device Products” will be send to you via email.
Fill out the form below to watch the webinar: “MDR Article 16 – What Does It Mean For Importers and Distributors of Medical Devices”
Fill out the form below to watch the webinar: “MDS 1014 – Medical Devices incorporating IVD”
Fill out the form below to watch the webinar: “Webinar MDR Article 117”
Fill out the form below to watch the webinar: “Medical Software and AI“
