MedTech Regulatory Strategy Support. How It Should Work?
Developing a MedTech product means you need to connect many dots. Clinical, business, technical aspects and MedTech regulatory. But today I’d like to keep your focus on regulations that are essential to ensure the safety and effectiveness of medical devices, always keeping the patient’s well-being at the forefront. Let me guide you through the process and show you how we approach it at Consonance.
MedTech Regulatory – Key Facts
Let’s start with the basics.
The most important piece of legislation regulating the production of medical devices in the European Union is Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, commonly known as the MDR (Medical Devices Regulation). Its primary objective is to ensure a high level of safety and quality for medical devices across the EU. Compliance with the MDR is mandatory.
Placing a non-compliant product on the market carries severe sanctions, which vary depending on the country. Here are some examples from EU countries:
- Poland – the penalty can be a fine of up to PLN 5,000,000 (1,2 M Euros),
- Germany – serious violations such as intentional acts that endanger health and are motivated by profit can lead to imprisonment for up to 10 years, while standard violations (e.g., lack of conformity assessment or unauthorized CE marking) may result in up to three years’ imprisonment. Additionally, breaches of the MDR or MPDG (Das Medizinprodukterecht-Durchführungsgesetz), such as failure to conduct post-market surveillance, can incur fines of up to €30,000,
- Spain – fines can reach €300,000, along with bans on operations lasting up to five years.
Complementing the MDR, though not legally required, is ISO 13485, an international standard that defines the requirements for a quality management system specifically for medical device manufacturers. While its implementation is voluntary, it is highly recommended, as ISO 13485 significantly facilitates demonstrating compliance with MDR requirements.
During the design process, it may turn out that some features or elements are very costly to implement. That’s why it’s important to know from the beginning what’s the core and essential, and what can potentially be left out if the budget becomes a constraint.
What is MedTech Regulatory Strategy Support?
This is a comprehensive support service provided by quality management specialists to assist companies in implementing technical documentation and navigating complex regulatory requirements throughout the product lifecycle – from development and approval to post-market compliance. A strong regulatory strategy ensures faster device time to market, fewer regulatory setbacks and long-term compliance.
How Does it Work at Consonance?
One of the key pillars of our MedTech product development process is the implementation of a regulatory strategy for your medical device before the engineering process actually starts. And there’s a strong “why” for this approach.
Any technology solution in MedTech must meet certain criteria to become approved for further commercialization. This applies not only to the European market under Regulation (EU) 2017/745 (MDR), but also to other key markets such as the U.S. (FDA) and the UK (UK MDR), where regulatory expectations must be addressed early in the development process to speed up global market access. This is part of the comprehensive support we offer our partners, from initial analysis to successful product launch. Our team has over 10 years of experience working in compliance with European medical device legislation, including the Council Directive 93/42/EEC (MDD) and the currently applicable MDR.
Throughout this period, our operations have consistently adhered to the requirements of ISO 13485. We have successfully completed more than 100 projects, seamlessly combining regulatory expertise with practical implementation within an engineering framework.
What can you expect?
- Implementation of ISO 13485 for companies planning the manufacturing of medical devices,
- Support in obtaining CE marking for medical devices in accordance with Regulation (EU) 2017/745 on medical devices (MDR),
- Support in obtaining CE marking for medical software (SaMD – Software as a Medical Device) in accordance with Regulation (EU) 2017/745 on medical devices (MDR),
- Audit of technical documentation for medical devices and medical applications,
- Preparation of certification strategies for medical products and systems.
MedTech Regulatory compliance is mandatory.
Transparent Approach to MedTech Regulatory
We begin the certification strategy planning process as early as Stage 0, in the Technical Feasibility Study (TFS) report. As part of the comprehensive report, we analyze whether the device meets the definition of a medical device and classify it into one of risk classes. At this stage, we also review all applicable standards and regulations relevant to the product. During the TFS, we prepare a list of the required technical documentation that must be in place for the product to be marketed. Additionally, we develop a description of the quality management system in compliance with MDR requirements. Based on the TFS, we create a detailed project plan, including a breakdown of tasks, estimated timelines, and costs.
Let’s explore how MedTech regulatory process looks like with the help of the Consonance team:
- Device qualification
- Risk classification
- Regulatory and normative requirements analysis
- Key activities in parallel
- Implement a Quality Management System compliant with ISO 13485.
- Initiate and conduct clinical evaluation or performance evaluation, depending on the product type.
- Develop comprehensive technical documentation to support regulatory compliance.
- Coordinate and manage required testing with accredited laboratories.
- Provide expert guidance and oversight throughout the process to ensure alignment with regulatory expectations.
- Conformity assessment and CE marking
- Market launch
We begin by verifying whether your product meets the definition of a medical device under MDR. If it does, we proceed to the next steps.
We determine the product’s risk class, which defines the appropriate conformity assessment procedure.
We develop a tailored map of all applicable regulations, standards, and guidance documents based on the product and its intended purpose.
Client responsibilities:
Our support:
Once all preparatory steps are complete, the product is ready for an audit by a notified body. You will need to engage and coordinate with the selected notified body to undergo the conformity assessment. Upon successful completion, the product will be awarded the CE marking.
With all requirements fulfilled, the product can be legally placed on the market within the European Union.
Final Conclusion
MedTech regulatory strategy is something you should consider right from the start of developing a medical device. We understand that you might not yet know where to begin or exactly what needs to be done and that’s completely normal. Still, planning your regulatory activities early on is essential to ensure user safety, give yourself peace of mind and avoid potential penalties.
Have more questions? Don’t want to navigate the process alone?
