EU MDR Annex I GSPR 10: What Notified Bodies Actually Check

What GSPR 10 Actually Covers

GSPR 10 addresses chemical, physical, and biological properties. For the biocompatibility part of the file, the practical question is whether the device is designed and manufactured in a way that minimizes risks related to contaminants, residues, leachables, degradation products, and other biologically relevant material issues.

In practice, reviewers expect the Technical File to show that these risks were not handled casually. They want to see the materials context, the biological evaluation plan, the evidence assessment, and the final residual-risk logic tied together in a way they can follow.

What Notified Bodies Actually Check

Based on recurring query patterns, these are the parts of the file that receive the most scrutiny:

• Completeness of the biological evaluation: is there a real BEP and BER, and do they cover the correct endpoints for the device's contact type and duration?
• Currency of the file: does the biological evaluation reflect current ISO 10993 expectations, or does it still read like an older MDD-era document?
• Chemical characterization and TRA: for longer-contact devices, is the chemistry story strong enough to support the biological safety conclusions?
• Link to risk management: do the biological hazards and residual-risk conclusions align with the ISO 14971 risk file?
• Post-market linkage: is there a mechanism in PMS or PMCF to detect biological safety signals after market entry?

The GSPR 10 Sections That Usually Matter Most

For practical biocompatibility work, reviewers tend to focus on the parts of GSPR 10 that relate to contaminants, residues, substances that can leach or degrade from the device, and unintended ingress of substances into the device. If the file does not show how these risks were assessed, the Technical File often feels incomplete even when test reports exist.

The SVHC and CMR Requirement

One of the most important EU MDR additions for legacy files is the need to identify and justify substances of very high concern, CMR category 1A/1B substances, and related high-risk material issues where relevant. Many older technical files contain a BER but no visible SVHC or CMR assessment. That is a common notified body query theme for devices transitioning from MDD-era documentation.

Why Legacy Files Often Struggle

Many legacy files contain reasonable scientific content but poor EU MDR framing. Common problems include:

• The BER is isolated: the report exists, but the Technical File does not show how it satisfies GSPR 10.
• Materials context is too thin: reviewers cannot clearly see the patient-contacting materials, coatings, sterilization state, or relevant process context.
• No link to Annex II structure: the biological evaluation reads like a standalone attachment instead of a controlled part of Technical Documentation.
• No explicit lifecycle or residual-risk framing: the file may state acceptability, but not in a way that aligns with current expectations.

What a Strong GSPR 10 File Looks Like

A strong file makes the logic easy to audit. The notified body should be able to move from device materials, to endpoint strategy, to chemistry and toxicology where needed, to endpoint conclusions, to residual risk, and finally to the Technical File narrative that claims GSPR 10 is addressed. When that chain is visible, review friction drops.

Practical Checklist Before Submission

• Confirm the file clearly identifies the patient-contacting materials and final device state.
• Make sure the BEP and BER logic can be followed from planning to conclusion.
• Check whether chemistry and TRA are needed for the contact profile and material complexity.
• Confirm any SVHC or CMR concerns are addressed where relevant.
• Cross-reference biological conclusions to the risk-management file and, where needed, PMS/PMCF logic.