List of Standards and Regulations for Medical Devices: In 4 Steps
- Arlette Schilter
- Nov 15, 2024
- 4 min read
Updated: Jul 1
List of Standards and Regulations for Medical Devices is a document that lists standards, regulations, pharmacopeia, and essential guidelines to fulfill for CE Registration and other market approvals. It has an impact on development, testing, and QMS.
ColabON Presents a Strategy for the List of Standards and Regulations for Medical Devices
Focus on fewer, but the essential international standards.
Standards and Regulations define Safety and Performance Requirements
Timing: Before Product Design and Development to avoid costly development loop.
Medical devices are heavily reliant on standards because of the vast variety of medical devices. Selecting the right standards from MILLIONS requires strategy and experience. Over time, requirements start to overlap, and it becomes challenging to maintain an overview.
Step 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.
Step 2: Standards
Harmonized Standards and "Recognized Consensus Standards: Medical Devices"
Legal Reference: MDR Article 8 – Use of harmonised standards
EU-MDR or IVDR Harmonized Standards are supporting GSPRs (Annex I). With the help of harmonized standards, demonstrating compliance is easier.
There are MILLIONS of standards out there. This is why the FDA and the European Commission have made these lists in the first place.
There are harmonized standards that reference unharmonized test standards. You may or may not add the applicable ones to the list.
There are also harmonized standards that must be fulfilled by vendors. But since they are harmonized, put them on. They need to appear in the vendor documentation.
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.
Step 3: Pharmacopeia for EU and U.S.
Pharmacopeia: If your device touches a drug — don’t skip this
European Pharmacopeia: Article 8 - Use of harmonised standards, 2. talks about European Pharmacopoeia
United States Pharmacopoeia (USP)
Refer to USP General Chapters applicable to device-drug combination products
Evaluate monographs for materials tested under federal food, drug, and cosmetic act provisions
Consider USP <661>, <661.1>, <661.2> for plastic packaging components and extractables/leachables studies
Coring, Fragmentation, Material Properties etc.
Some ISO standards have good summaries of a good selection of Pharmacopeia parts. We recommend to use a vertical (product) standards to justify the selection and not get lost.
Step 4: Guidelines and Common Specifications
Legal Basis in MDR Article 9:
"where no harmonised standards exist or where relevant harmonised standards are not sufficient"
European Guidelines
Only include guidelines that fill documented compliance gaps. Examples: MDCG guidelines for Clinical Evaluation
FDA Guidelines
These guidelines are not legally binding, but provide a useful summary of FDA expectations.
International Guidelines
There are some guidelines that apply internationally. And on specific countries. Please also consult these.
Guidelines should generally be avoided on the master standards list. While guidelines serve as excellent reference material and significantly aid understanding, they often become outdated quickly. Include only those specifically referenced in regulations or necessary to address identified compliance gaps.
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
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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