New IVDR - confinis

Regulatory Compliance for AI-Enabled Medical Devices

Medical Devices Cybersecurity Checklist

Medical Devices Threat Modeling

New confinis Cybersecurity Services

(EU) 2023/607, 26th May 2024 deadline approaching

The Future of Health Grant welcomes confinis as a new Program Partner

Transitioning to the Medical Device Regulation (MDR) 2017/745

Deadline for transitioning to the Medical Device Regulation

A Step Forward in Medical Device Manufacturing: the New QMSR Aligned with ISO 13485:2016

The EU Artificial Intelligence Act and Medical Device Regulation with Andrea Biasiucci

Leveraging Real-World Evidence: Insights and Guidance for Medical Device Manufacturers

confinis ag appoints Dario Motti as lead of new Digital Health Competence Cluster

Change in Management Structure with Appointment of New CEO at confinis ag

The Medical Device Regulation and the medical care for children and rare diseases

Working at confinis and the IVDR world with Barbara Jeroncic

IVD News – IVDR Date of Application, new Guidance Documents

confinis and deep tech with Andrea Biasiucci

Electromagnetic Compatibility (EMC) of Medical Devices

IVD News – Progressive Roll-Out and MDCG 2022-2 on Clinical Evidence

UK Responsible Person Services

confinis launches new UK Responsible Person service in UK

ISO/FDIS 11608 series opened for voting

confinis partners with Irdeto to launch the first cybersecurity assessment tool in the medical devices industry

confinis offers Swiss Representative Service

Exporting Swiss Medical Devices to the EU

Join our Startup Workshop 2021!

… and Report your Post-Market Clinical Follow-up Evaluation!

How to plan your post-market clinical follow up…

How does the notified body assess your clinical evaluation?

How to perform a clinical evaluation for Medical Device Software

How to ensure sufficient clinical evidence for legacy devices

How to claim an equivalence in the clinical evaluation under the MDR

Novelties for Clinical Evaluation and Post Market Surveillance within MDR – the Posts Series

Bei Medizinprodukten auf die EU warten hilft der Schweiz wenig

Clinical and Performance Evaluation – our 5 strengths at your service

confinis partners with b-rayZ concerning innovative Artificial Intelligence project

Join us at world’s leading AI in medicine summit!

Revision der Schweizer Medizinprodukteverordnung mit Folgen

Workshop: Software as a Medical Device (SaMD) in Zürich

Interpellation Jacqueline de Quattro on medical devices

confinis celebrates 15th anniversary

Web based tool to analyze effect of significant changes to devices covered by MDD or AIMDD certificates

Politics intervene regarding medical devices

Development of medical devices to tackle COVID-19 – UPDATE

Swiss Medtech Umfrage: Export in die EU mit Drittstaatanforderungen sichern

Peter Studer joins confinis as Senior Advisor

EU MDR audit requirements and links to MDSAP program

From “Essential Requirements” to “General Safety and Performance Requirements” – EU MDR 2017/745

Technical Documentation for medical devices under the new European MDR

Conformity Assessment Procedures and Premarket Scrutiny under EU MDR

Classification of medical devices under the European Medical Device Regulation 2017/745

#MDR – Transition periods and definitions

Work in progress: MDR implementation – impact on your Quality Management System (ISO 13485:2016)

Your insight to: confinis and its partners – work in progress regarding MDR implementation

MDR Article 117 – a look into the Crystal Ball (Part 6)

From Investigator to Consulting: On the other side of the fence

MDR Article 117 – a look into the Crystal Ball (Part 5)

WORKSHOP: PMS under the new European MDR

“Quick Wins” for your MDR implementation

MDR Article 117 – a look into the Crystal Ball (Part 4)

MDR Article 117 – a look into the Crystal Ball (Part 3)

MDR Article 117 – a look into the Crystal Ball (Part 2)

MDR Article 117 – a look into the Crystal Ball (Part 1)

confinis opens US office in the Washington DC area

MDR Article 117 – are Combination Product Manufacturers prepared?

New year, new energy!

Beat Steffen to speak at Medtech & Pharma Platform in Basel

Upcoming ISO Technical Report regarding Post Market Surveillance

Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR): Impact on Switzerland

New IVDR Compliance: Get Ready with confinis

Urgency of Compliance

The transition period for the new European In-vitro Diagnostic Medical Devices Regulation (IVDR, (EU) 2017/746) is nearing its end. Having replaced the older In-vitro Diagnostic Medical Devices Directive (IVDD, 98/79/EC), the new regulation mandates full compliance by May 26th, 2022. This tight deadline makes it imperative for manufacturers and stakeholders in the diagnostic medical devices industry to ensure their products meet the new standards promptly.

How confinis Can Help

At confinis, our in-vitro diagnostic medical device experts are equipped to guide you through every step of the IVDR implementation process. From initial assessment to final certification, our comprehensive support includes:

Why IVDR Compliance is Critical

Strategic IVDR Compliance Planning
We develop a tailored strategy that encompasses all aspects of IVDR compliance, ensuring that your approach is both pragmatic and effective. This strategy will focus on establishing or enhancing your Quality Management System, refining product technical documentation, and facilitating smooth submissions and interactions with notified bodies.
Technical Documentation and Quality Management
Our experts will assist in preparing and reviewing the necessary technical documentation required under IVDR. This includes performance evaluations, clinical evidence reports, and risk management files, all aligned with the stringent requirements of the new regulation.
Notified Body Interaction
With extensive experience in regulatory affairs, our team will support you in managing communications with notified bodies, ensuring that your compliance efforts are recognized and validated without delays.

Achieving compliance with IVDR is not just about adhering to legal requirements—it’s about securing your market presence in Europe and other international markets that recognize the European CE marking. Ensuring IVDR readiness is crucial for continued access to these markets and for maintaining the trust of consumers and healthcare professionals in the safety and efficacy of your diagnostic products.

Stay Ahead with confinis

Don’t let the compliance deadline catch you unprepared. Partner with confinis to navigate the complexities of IVDR and ensure your in-vitro diagnostic devices continue to meet the highest standards of market entry and patient safety.