The MDR: What Does It Mean? An Overview.

When assembling medical devices, among other products, we regularly encounter the Medical Device Regulation (MDR – Regulation (EU) 2017/745). This regulation imposes strict requirements on the design, assembly, documentation, and traceability of medical devices. Manufacturers developing and producing medical products must demonstrably comply with this legislation. In this blog, we guide you through the evolution of European medical device regulations. We’ll also discuss the differences compared to the previous directives, and what this means for production and assembly at BS&i Mechatronics.

From directives to regulation: the origins of the MDR

The regulation of medical devices began in the 1990s with three European directives:
– Directive 90/385/EEC (AIMDD – 1990): for active implantable medical devices such as pacemakers.
– Directive 93/42/EEC (MDD – 1993): for general medical devices, from bandages to surgical robots.
– Directive 98/79/EC (IVDD – 1998): for in vitro diagnostics, such as laboratory tests and pregnancy tests.

These directives applied to all EU member states. However, they first had to be transposed nationally. This created differences in interpretation and limited compliance monitoring.

The introduction of the MDR (EU 2017/745)

On May 5, 2017, the European Commission published the Medical Device Regulation. This regulation replaced the three directives mentioned above and has been in full effect since May 26, 2021.

The MDR is directly applicable in all EU member states and provides a uniform, stricter approach. It was introduced in response to several incidents, including the well-known PIP implant affair. And in part to better regulate innovative technologies such as software and smart medical devices.

What are the main changes with the MDR?

The MDR expands the scope and increases the requirements on manufacturers. Key changes include:
– Uniform legislation: the MDR is a regulation, not a directive.
– New product categories: aesthetic products and medical software are now included.
– More risk classes and stricter classification rules.
– Mandatory clinical evaluation for each product.
– UDI (Unique Device Identification) system for traceability.
– Post-market surveillance (PMS) and mandatory incident reporting.
– Registration in EUDAMED.
– Responsibility for all market participants.
– Mandatory appointment of a PRRC.
– Technical dossier according to Annex II and III of the MDR.

Transitional arrangement and updates

To keep the transition from the MDD to the MDR workable, a transition period was established. Regulation (EU) 2023/607 established that certain devices may remain on the market under the old certificates until 2027 or 2028, provided that:
– the device is still safe,
– no significant changes have been made,
– and the manufacturer is actively working towards MDR compliance.

This was followed in 2024 by the publication of Regulation (EU) 2024/1860, in which the European Commission further clarified these transitional rules and tightened controls on existing devices.

The role of BS&i Mechatronics

As a supplier of mechatronic devices for the medical sector, BS&i Mechatronics supports its customers in making their products MDR-compliant. Consider:
– Traceable assembly including serial numbering and process logging.
– Production under ISO 13485 conditions.
– Technical documentation and test protocols.
– Support for audits by Notified Bodies.

If requested by our client, we cooperate with Notified Bodies in the Netherlands and abroad.

Conclusion

The MDR is an essential milestone in the development of European regulation of medical devices. For manufacturers, this means not only higher requirements, but also greater safety, transparency and uniformity in the market. BS&i Mechatronics is ready to turn these complex regulations into a structured and reliable production process – from initial assembly to validation and documentation.

Do you have questions about this blog or other questions? Please feel free to contact us at Contact Us or call us at 0492 830126. Our team of specialists is ready to support you.