GSPR Checklist for EU MDR Annex I Conformity

EU MDR deliverable

What the GSPR checklist does

Annex I of EU MDR 2017/745 sets out the General Safety and Performance Requirements: 23 numbered requirements with many sub-clauses, replacing the Essential Requirements of the old directives. Every manufacturer must demonstrate conformity with each requirement that applies to the device, and justify the exclusion of each that does not.

The checklist is the instrument that does this. It is also the first document most notified body reviewers open, because it is the index to the whole technical documentation. A weak GSPR checklist makes a strong technical file look disorganised; a precise one makes review faster and cheaper.

How a GSPR checklist is built properly

Each row needs four things, and most checklists get the fourth wrong:

  1. The requirement, quoted or accurately paraphrased, at sub-clause level rather than as a whole numbered requirement.
  2. Applicability, with a justification where the answer is no. “Not applicable” on its own is a deficiency.
  3. The method of conformity — the harmonised standard, common specification or in-house method used, with the edition and year.
  4. The evidence reference — document number, title, version and the specific section or page. Not “risk management file”. “RMF-004 rev 6, section 7.3, pages 22 to 26”.

The requirements that cause the most work

  • GSPR 1 to 9, the general requirements — written in risk management terms and answered from the risk management file. If the risk file is weak, nine requirements fail at once.
  • GSPR 10, chemical, physical and biological properties — biocompatibility to ISO 10993, and the substances of concern declarations, including CMR and endocrine disruptor content above the thresholds.
  • GSPR 14.2 and 14.7 — devices with a measuring function and the ergonomic requirements, both frequently marked not applicable without justification.
  • GSPR 17, electronic programmable systems — software lifecycle to IEC 62304, repeatability, reliability and performance, plus IT security expectations.
  • GSPR 18, active devices — alarm conditions to IEC 60601-1-8 where applicable.
  • GSPR 23, labelling and instructions for use — the longest requirement in Annex I, with dozens of discrete items. Answering it as a single row is a guaranteed query; it needs a line per sub-item.

Where checklists go wrong

  • Answered at requirement level, not sub-clause level. GSPR 23 has more than fifty individual obligations. One row cannot evidence them.
  • Evidence references that point at whole documents. The reviewer must be able to turn to the page.
  • Superseded standard editions cited, or harmonised status assumed where the standard was never listed in the Official Journal under the MDR.
  • Not applicable without reasoning. Every exclusion is a claim, and claims need justification.
  • Left unversioned. When the risk file or the CER is revised, the checklist references go stale and nobody updates them.
  • Copied from an MDD Essential Requirements checklist. The mapping is not one to one; several MDR requirements have no MDD equivalent.

How the work runs

We build the checklist at sub-clause level, decide applicability with your technical team rather than for them, identify which standard answers each requirement, and then trace every row to a real document, section and version. Where a row has no evidence behind it, that becomes a gap on the project plan rather than a hopeful entry in the table. The checklist is written last in a technical documentation project, once the underlying evidence is settled, and maintained afterwards as a live index.

Frequently asked questions

What is the difference between Essential Requirements and GSPRs?
The GSPRs replace the Essential Requirements of the MDD and AIMDD. They are more numerous, more detailed, and add requirements on software, IT security, substances of concern and labelling that had no direct predecessor.

Do Class I devices need a GSPR checklist?
Yes. Annex I applies to every device in every class. Self-declaration does not remove the obligation to demonstrate conformity.

Can we mark a requirement not applicable?
Yes, with a justification recorded in the checklist. The justification is what a reviewer assesses.

Does the IVDR have GSPRs too?
Yes. Annex I of IVDR 2017/746 has its own set, structured similarly but adapted to in vitro diagnostics.

How often should it be updated?
Whenever a referenced document is revised, a standard is superseded, or the device changes. In practice, review it at every technical documentation update.

The GSPR checklist is prepared as part of CE marking and sits alongside the clinical evaluation report in the technical file.