Switzerland: MDR For Supply Chain 2021

Management summary

The new European Regulations on Medical Devices (EU 2017/745) increasingly impact healthcare and contribute to an industry-wide uncertainty on compliance. Due to Switzerland's bilateral agreements with the EU and the de-facto adoption of the EU regulations, there is a need for the Swiss healthcare industry to identify the best way to ensure compliance rapidly and efficiently with these regulations.

This includes the responsibilities of manufacturers, distributors and end users of medical devices and in vitro diagnostics. Moreover, for end users in particular, this current situation provides the opportunity for a global transformation, as the need for action can be readily transferred from pure compliance with the new regulations to meeting the long-term need for a more efficient Supply Chain Management.

Consulting with supply chain managers in Swiss hospitals, we have compiled this present report on the challenges and recommendations surrounding Supply Chain Management and compliance with MDR.

Based on our experience, we show how regulatory compliance and seminal transformation can be achieved with relatively small changes to the standard process. In particular, our main high-level recommendation is the adoption of risk-based management with lean, automated processes based on a high degree of digitalization.

1. Context of this report

The recent Regulations on Medical Devices and In Vitro Diagnostics (EU 2017/745-746) were passed to ensure a better risk management for patients. Though welcomed by some, the regulations impose a heavy burden on manufacturers, distributors and end users alike, as they require more stringent certification and tracking of products.

For manufacturers in particular, this entails high investments into an extended, risk-based product life cycle management, potentially leading to the discontinuation of products, for which the investments are not warranted. For distributors and end users, improved tracking infrastructures are necessary. Thus, the question arises of how to deal with the new mass of product information in the form of certificates and other documents in the best possible manner. Specific new processes for incoming goods need to be designed to handle different MDR risk classes and need to integrate multi-stakeholder reporting and feedback.

For Swiss hospitals, the Swiss Medical Device Ordinance imposes similar challenges. Regulators are already requesting audit visits, despite the hitherto absence of clear requirements on best practices and processes. The implicit assumption is that well-formed processes that appear compliant with EU MDR will be expected to pass these audits. However, without clear guidelines, there exist largely diverse opinions on the necessary and best-practice adaptations. Moreover, most adaptations mix pure compliance needs with long overdue process re-designs for the modernization of Supply Chain Management, making strategic evaluations and decisions more difficult.

With this report, we intend to provide a clear overview of the subject based on:

• Our in-house expertise
• Our long track record of helping manufacturers and distributors become compliant with MDR
• Interviews and reports on best practices within Swiss hospital procurement of more than 30 hospitals

The goal of this overview is to provide a well-informed, lean strategic decision-making guide to better prepare Swiss hospitals for a new and improved Supply Chain Management.

2. Overview of MDR regulation requirements

Most central for the applicability of the MDR is the risk classification and the current role - either as manufacturer, distributor or end user - of the device/diagnostic in question. For healthcare institutions, the concern is mainly with the requirements for end users and for high-risk devices and diagnostics.

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The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.