3 Steps for a good Selection of Standards and Regulations for Medical Devices
- Arlette Schilter
- Nov 15, 2024
- 3 min read
Updated: 2 days ago
Standards and Regulations for Medical Devices are essential to fulfill for CE Registration and Market Approval.
Standards and regulations for medical devices are not obstacles; they are the foundation for success, innovation, and trust. With the right strategy and tools, you can master regulatory requirements and bring safe, innovative products to market faster. But how can you achieve this?
Focus on the right standards and regulations for interpretation
Choosing the right standards and regulations for medical devices is critical—because it's all too easy to get lost heading in the wrong direction.
Medical Devices are heavily reliant on standards because of the vast variety of medical devices. Selecting the right standards from thousands requires strategy and experience. Over time, requirements start to overlap, and it becomes challenging to maintain an overview.
LESS IS MORE – BUT TIMING IS OF THE ESSENCE!
We provide the answers and share the 3 success factors for efficiently managing standards and regulations in medical devices and ivds.
1. Choosing the Right Standards and Regulations for medical device
The first step to success: Select the standards and regulations that are truly relevant for your products. Put these on a list. This list is called List of applicable standards and Regulations.
Leverage approvals from previous products or seek support from a notified body or the FDA.
1.1 Regulations
The regulations are either the MDR or the IVDR for Europe, and the various CFRs for the United States.
EU-AI Act, and RoHS or other regulations might also apply.
1.2 Standards
Choose from the list of harmonized standards for European CE Marking
From the list of consensus standards for U.S.
Here are a few process standards we suggest.
1.3 Pharmacopeia
Pharmacopeia: If your device touches a drug — don’t skip this
1.4 Guidelines
Guidelines are a great read and really help.
Guidelines: Only add the ones that fill a gap.
Timing is crucial. Define product requirements before starting development to avoid costly redesign loops. Standards act as a design input for products.
Tip for Startups: Don’t waste weeks or months. Consult our experts—we’ll provide you with a curated and justified list of applicable standards. This is the single best investment you can make in compliance.
2. Provide Data: Standards and Regulations for medical device
Reliable Information Through High-Quality Data
An incorrect or incomplete data foundation can jeopardize your project. With the high-quality, always up-to-date data from ColabON, you can avoid delays and compliance risks.
Automatic updates whenever standards or regulations change.
Data quality that makes a difference.
Faster approvals, earlier sales enabled by up-to-date data and traceability.
3. Interpret Standards and Regulations for Medical Devices
3.1 Use these Rules for Prioritization for Product Requirements
🎯 Start with vertical standards
→ These apply directly to your type of device
→ Example: IEC 60601-2-xx (specific electrical safety)
Then…⚖️ Add horizontal standards
→ They’re broad
→ Read Guidelines about them
→ Understand which TEST CASES will be expected
→ They’re hard to interpret without expert input
🗣️ What else should you do?
✅ Talk to your Notified Body
Ask: “What test reports do you expect?”
✅ Talk to your Vendors
They know their standards inside out
✅ Talk to Us
Especially if you’re dealing with IEC 60601-1 or process standards
3.2 Detail Steps for Standard and Regulation Interpretation
✔ Read the Scope First – It may not even apply to your case.
✔ Scan the Appendices – Often, the most valuable insights are there, guiding you on what to do.
✔ Read the Headings & Table of Contents – Helps to get an overview before diving into details.
✔ Mark Non-Applicable Chapters – Set them aside early to focus on relevant content.
✔ Consult Trusted Online Sources – Summaries from reliable sources can provide clarity.
✔ Look for Guidelines – FDA, IMDRF, MDCGs often publish helpful interpretation guides.
✔ Read in Sections – Avoid information overload.
✔ Take Notes – Capture key insights for later reference.
✔ Define Requirements & Link to Them – Ensure traceability for compliance.
✔ Ask for Expert Help – Engage manufacturers, test labs, and compliance specialists.
Learn More about our service here.
Transparency and Trust Through Digital Solutions
Transparency builds trust—both internally and externally. With ColabON's digital provision of standards and regulations, you can improve understanding across your entire team.
Data visualization: Your employees can grasp complex requirements more easily.
Accessibility for the entire company: A tool that connects and informs everyone.
Traceable interpretations: Linked data in ColabON ensures clear and consistent understanding.
Achieve Success: Innovate with ColabON
Standards and regulations in medical technology are opportunities, not obstacles. By using ColabON’s reliable data, expert guidance, and digital solutions, you can set a foundation for trust, compliance, and innovation.
Ready to get started?
Contact us today and learn how ColabON can support you!
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