List of Applicable Standards (LOAS) for Medical Devices
A list of applicable standards built for your device, not copied from a template. We identify the standards your device needs and map them to your GSPR checklist and technical file.
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What Is a List of Applicable Standards (LOAS)?
A list of applicable standards (LOAS) is a controlled document that records every standard a manufacturer applies to show that a medical device is safe and performs as intended. For each standard, it records the reference and version, whether it is harmonised, and which General Safety and Performance Requirements (GSPR) it supports.
Under Annex II, of the MDR, your technical documentation must identify the harmonised standards, common specifications or other solutions applied to demonstrate conformity with each GSPR. The LOAS is where this information is managed and kept current. As an EU MDR consultant, 3i Concept helps medical device and drug-device combination product manufacturers build a LOAS that is accurate, current and consistent with the rest of the technical file.
Why the LOAS Matters for CE Marking
A well-maintained list of applicable standards is often the fastest way for a Notified Body to see how your device meets the GSPR.
Presumption of conformity
Applying harmonised standards gives a presumption of conformity with the GSPR they cover.
State of the art
Where no harmonised standard exists, you must still show your device reflects the state of the art.
Notified Body review
Reviewers check that the standards in your LOAS, test reports, GSPR checklist and Declaration of Conformity are consistent.
Change control
When a standard is revised, you need a documented assessment of whether it affects your device.
How to Identify the Standards That Apply to Your Device
Building the right list of applicable standards follows four steps, from harmonised standards to version control.
Start with Harmonised Standards
Check the current MDR harmonised standards list first. These give a presumption of conformity with the GSPR they cover.
Add Product-Specific Standards
Include standards that apply to most devices, such as quality, risk, usability and labelling, plus those for your device type.
Cover the State of the Art
Add recognised ISO and IEC standards that are not harmonised, along with common specifications and relevant MDCG guidance.
Verify Versions
Confirm the current edition and amendments of each standard before you reference it in your technical file.
Types of ISO Medical Device Standards in a LOAS
A typical LOAS covers standards in these areas, depending on the device:
- Quality management: such as ISO 13485.
- Risk management: such as ISO 14971.
- Usability: such as IEC 62366-1.
- Biocompatibility: the ISO 10993 series.
- Sterilisation and packaging: standards for the sterilisation method and sterile barrier systems.
- Labelling and IFU: standards for symbols and information supplied by the manufacturer.
- Software: such as IEC 62304, for devices that include or are software.
- Electrical safety: the IEC 60601 series, for active devices.
- Clinical investigation: standards for clinical investigations on human subjects.
Standards for Drug-Device Combination Products
Combination products need standards covering both the device part and its interaction with the medicinal product. For injection devices, this typically includes the ISO 11608 series for pen injectors and auto-injectors, and the ISO 11040 series for prefilled syringes.
For integral products submitted under Article 117, these standards support the evidence that the device part meets the relevant GSPR for the Notified Body Opinion. Through our drug device combination product consulting service, we make sure your LOAS covers both sides.
Common LOAS Mistakes
- Outdated standard editions carried over from MDD-era files.
- Standards listed but never linked to a specific GSPR.
- Different standard versions quoted in the LOAS, test reports and Declaration of Conformity.
- No impact assessment when a standard is revised.
- Missing product-specific standards for the device type.
Our LOAS Services
- LOAS preparation: a device-specific list of applicable standards built from scratch.
- Standards gap assessment: an MDR gap analysis of your existing LOAS against current harmonised standards and the state of the art.
- GSPR mapping: linking each standard to the requirements it covers, starting from a GSPR checklist template tailored to your device.
- Revision impact assessment: reviewing what changes when a standard is updated, and what testing or documentation it affects.
- Combination product standards: identifying device standards for Article 117 submissions.
- Technical file alignment: as part of our support for EU MDR technical documentation, keeping your LOAS, test reports and Declaration of Conformity consistent.
Our Process
Review
We assess your device, intended purpose and existing LOAS.
Identify
We select the harmonised, product-specific and state-of-the-art standards that apply.
Map
We link each standard to the relevant GSPR and supporting evidence.
Maintain
We monitor standard updates and assess their impact on your technical file.
Subhash Meena
Medical Device & Drug-Device Combination Product Expert
Why Choose 3i Concept
Our standards work is led by Subhash Meena, a medical device and drug-device combination product expert with 15+ years of experience across Meril Life Sciences, Sun Pharmaceutical Industries, Amneal Pharmaceuticals and Dr. Reddy’s Laboratories. His hands-on work with pen injectors, auto-injectors and prefilled syringes, along with direct Notified Body filing experience, means your LOAS is built by someone who knows how it is reviewed.
15+
Year of Experience
4
Leading Companies
NB + USFDA
Direct Fillings
Frequently Asked Questions
A controlled document listing every standard applied to a medical device, with its version, harmonisation status and the GSPR it supports.
The MDR does not use the term LOAS. It does require your technical documentation to identify the harmonised standards, common specifications or other solutions applied for each GSPR, under Annex II, Section 4. A LOAS is the usual way to manage this.
Harmonised standards give a presumption of conformity with the GSPR they cover, under Article 8. Non-harmonised standards can still show the state of the art, but you need to justify how they demonstrate conformity.
Start with the harmonised standards list, add horizontal standards such as quality and risk management, then add product-specific and state-of-the-art standards for your device type.
Whenever a relevant standard is revised, harmonised or withdrawn, and at each periodic review of your technical documentation.
Alongside general device standards, injection devices typically need the ISO 11608 series for pen injectors and auto-injectors, and the ISO 11040 series for prefilled syringes.
Yes. We check your LOAS against current harmonised standards and the state of the art, identify gaps, and align it with your GSPR checklist and technical file.
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