MDR 2017/745 and the Future of Polymers in Medical Devices
Markus Bayer
Business Development Manager - Healthcare
Ultrapolymers GmbH
As a BDM for Ultrapolymers Germany, Markus Bayer has over 10 years’ experience in plastics, both in development and manufacturing. Since the start of 2024, he’s been actively involved in supporting Ultrapolyners Healthcare customers innovate, coupling his extensive polymer knowledge with extensive experience on the regulatory side of the industry.
In this article, Markus Bayer, a member of the Ultrapolymers Group Healthcare Team, dives into MDR 2017/745 to understand the impact it will have on material selection, development, and compliance.
The medical and healthcare sectors are undergoing significant change, driven largely by evolving regulatory frameworks. Central to this transformation are the MDR (Medical Device Regulation) changes, which are reshaping how manufacturers approach the design and development of medical devices. This also applies to the selection of the polymer.
The new legislation imposes stricter requirements for technical documentation, clinical studies, traceability, post-market surveillance, and other related aspects. These are all issues that cover the entire development period. Crystallising the right polymer at an early stage is therefore essential, as it saves time, resources and therefore money.
What’s Changing: An Overview of MDR and UK Requirements
The European Union's Medical Device Regulation (EU) 2017/745. Through the years, we have seen further updates and extensions made to the MDR that continue to challenge manufacturers' timelines and processes.
For the UK, leaving the EU has led to the emergence of the UK MDR standards, with future updates expected to mirror aspects of EU regulations, introducing additional layers of complexity. These medical device regulations in the UK are being watched closely by businesses seeking to maintain market access across both Europe and the UK.
Switzerland and the MDR 2017/745
When the EU’s new Medical Device Regulation (MDR 2017/745) came into effect on the 26th of May 2021, the rules for trading medical devices between the EU and Switzerland changed significantly. Because the agreement that normally recognises each other’s regulations (called the Mutual Recognition Agreement, or MRA) wasn’t updated in time, Switzerland is now treated as a “third country” by the EU.
This means Swiss manufacturers selling into the EU must appoint an authorised representative based in the EU (EU-REP), and EU manufacturers selling into Switzerland must do the same with a Swiss representative (CH-REP). There are also extra requirements for labelling and product registration.
Although Switzerland has aligned most of its own medical device laws with the EU’s MDR, the lack of an updated agreement still creates barriers for businesses. Political talks on a new framework have restarted, but so far, there’s been no clear progress on the medical device trade.
The Impact on Materials and Polymers
One of the most immediate effects of the new rules is the impact of MDR on polymer materials. As devices are re-classified and re-evaluated, materials that were once widely accepted may now face greater scrutiny. This affects everything, from material selection under MDR to the validation and documentation of ( the material-application combination)materials.
Key changes include:
- Increased expectations for biocompatibility data.
- Specific requirements on CRM which is also can be derived to the polymers. There fore traceability, formulation consistency, and a stable processing is mandatory.
- A sufficient lead time for re-evaluation in case of changes (notification of change, NoC)
These changes are not limited to “new” devices. Even existing devices must be re-certified under the new MDR regulations, forcing many companies to revisit long-standing, well-established designs.
MDR and the Design & Development Process
The impact of MDR on development and re-evaluation are far-reaching. Responsible persons, quality teams, and notified bodies must now collaborate earlier in the process and incorporate compliance into every stage of innovation.
The road from idea to production is long and businesses need to consider plenty of tasks like:
- (re) evaluate polymers in medical device production for compliance and biocompatibility.
- Adjust their MDR production process to ensure traceability, control, and repeatability of material usage.
- Factor in healthcare material innovation under MDR, considering next-generation polymers designed to meet tighter safety profiles and regulatory clarity.
Moving Forward: Challenges and Opportunities
While the changes in medical healthcare regulations pose short-term challenges, they also offer long-term opportunities. Companies investing in robust processes, smart polymer selection, and forward-thinking compliance strategies are better positioned to lead in an increasingly demanding global market.
Innovation remains critical, but innovation must be paired with evidence, transparency, and responsiveness to changing regulations. Success now depends not only on performance, but also on how clearly that performance can be validated under a complex and evolving regulatory landscape.
How Ultrapolymers Can Support You
At Ultrapolymers, we recognise the complexity of MDR and the increasing demands for materials used in the healthcare sector. Our dedicated Healthcare Team works with product developers, regulatory managers, and designers to support:
- Polymer selection with very strict requirements
- Advice on MDR compliant materials and on VDI 2017?
- Support for biocompatibility documentation and traceability
- Access to innovative materials meeting medical device regulations and polymer guidelines
- Constant Quality
- Safety during shortages
Whether you're re-certifying legacy products or designing new ones, we're here to help you de-risk development, innovate responsibly, and move forward with confidence.
Contact the Ultrapolymers Healthcare Team today to explore how we can support your regulatory and material strategy.
