Understand the Challenges | Common Pitfalls to Avoid in Technical Documentation under the Medical Device Regulation (MDR)

A Technical Documentation (TD) submission under MDR can yet be challenging for clients who have become accustomed to submitting files and dossiers under MDD. Although much has been said about the more prescriptive requirements on everything from TD formatting to the discussion of various testing available for a device, I would like to focus today on some of the items that can be easily remedied when submitting a TD to a Notified Body.

The typical time to reach MDR certification (counting both QMS plus device) has been reported from 13-24 months. Many Notified Bodies, in their effort to keep up with the number of clients and MDR submissions, have streamlined their review processes to focus, in the first round of review, primarily on receiving the appropriate content in a submission (i.e., Annex I-IV of MDR), after which rounds 2-3 of questions have been centered on the quality of the submission itself. (Some Notified Bodies may have more than 3 rounds of questions, but the number will be limited.)

Therefore, first and foremost, it is extremely beneficial for clients to perform the appropriate quality assurance checks on their submissions to ensure that the appropriate content for Annex I-IV has been submitted, to maximize the review time spent on the quality itself during the reviews.

Common pitfalls for Technical Documentation to avoid

Here are some of the most important considerations to avoid common content ‘’checklist’’ pitfalls for Technical Documentation:

1. Ensure a ‘’completeness check’’ for your MDR TD File – a gap analysis to Annex I-IV, focusing on content requirements. BSI, for example, provides an “MDR Technical Documentation Completeness Check’ to its clients, but your NB may provide a different format. If not, it is highly recommended to build such a checklist internally and to utilize it as a quality assurance measure before submission. Some items that are often overlooked include –
   1. Declaration of novel features (or justification if there are none)
   2. Similar devices available in markets – also a requirement for the Clinical Evaluation, PMCF, and PSUR. There is a table in MDCG 2020-7 helpful in listing similar devices – this could be leveraged across multiple documents.
   3. Device Validation & Verification (V&V): This section is often underdeveloped in TD submissions. Ensure that there is an overview of the full Design Process, including all levels of design inputs. If the device is a legacy device, explain the approach and rationale for any leveraged tests. All test protocols and reports for V&V evidence should be provided upon submission, and there should be evidence of performance over the lifetime of the device.
   4. PMS section – all Annex III requirements should be included.
   5. List of standards which are claimed for compliance – present proactively a clear gap analysis if older versions of standards are used and most updated tests are provided in the latest standard.
   6. Hazardous substances justification (Annex I, GSPR 10.4)
   7. Device disposal procedure/justification (Annex I, GSPR 14.7), and IFU requirement for disposal procedure (GSPR 23.4v)
   8. Include labeling/IFUs (in English, but labeling/IFUs should be available for all EU member states where the device is projected to be sold). ER 13 is not identically equivalent to GSPR 23, so special attention should be paid to this GSPR regarding labeling. Software medical devices are also expected to have a label!
   9. EU Website should match patient information (IFU/labeling) provided in GSPR 23
   10. IFU: list residual risks (Annex I, GSPR 23.1g), clinical benefits (GSPR 23.4c), performance characteristics (GSPR 23.4e)
   11. Symbols as required by ISO 15223 (Annex I, GSPR 23.4f)
   12. If the device is an implant, do not forget to include the implant card in your TD (Annex I, GSPR 23.4aa)
2. Ensure all supporting documentation/testing is included in the TD, not just ‘’top-level’’ documents.
3. Include a table of contents that follows the structure, at a minimum, as presented in Annex II and III for the Technical Documentation. (There may be additional guidance from your NB regarding the desired structure of the TD.) If the content is provided in PDF or Word format, hyperlinks from the table of contents are extremely helpful to allow for ease of movement through the document review process (i.e., make the documentation a numbered, fully searchable, bookmarked PDF and easy for the reviewer to navigate).
4. Make sure all related MDCG guidance is followed and incorporated into the TD.
5. Ensure that the data provided in the TD is consistent with the data provided in the Notified Body application forms.
6. In information that is duplicated – i.e., intended use/user, UDI, warnings/contraindications/precautions, residual risks, clinical benefits and clinical risks, etc. – ensure consistency and verbatim verbiage.
7. Ensure that reports are complete. Abbreviated or partial test reports are not considered acceptable.
8. It is not acceptable to reference/leverage tests from the same device or another device that was ‘’previously reviewed under MDD’’ without providing these test protocols/reports.
9. For legacy devices:
   1. If the device has a long history under MDD, due to device changes and/or company acquisitions, all testing must be presented and explained clearly. Even if each change was reviewed under MDD, MDR is a stand-alone application with no grandfathering.
   2. If it is not clear what testing was performed on what version, or what other testing was leveraged/justified over time, please clearly outline this to avoid questions. This also applies to clinical data obtained on any historical version of the device. If equivalence is claimed, this will need to be justified clearly (per MDCG 2020-5).
   3. Do not provide design verification/validation reports with no context or explanation – this will increase review time and cost.
10. For GSPRs in Annex I:
    1. All applicable and non-applicable requirements should be clearly noted, with rationales for each.
    2. All applied standards, common specifications and guidances should be identified, including the extent of compliance (full/partial) and version/year. Also, if additional directives and regulations apply (i.e. Animal Tissue, Machinery), these should be listed.
    3. The ‘’precise identity of the controlled documents offering evidence of conformity’’ (Annex II, Section 4.d) should be identified, including document location (i.e., Technical Documentation, Section X, Biocompatibility). 

A strategic approach for EU MDR submission

Following the above, clients can ensure a more strategic approach from the very beginning of their EU MDR submission, to ensure that their Notified Body has the maximum time available to review the applications for the quality of the content. As this often happens in Round 2 and Round 3, there are some content areas that receive more questions than others in these later rounds:

1. State-of-the-art
2. SSCP
3. PMCF Plans
4. Safety and Performance Objectives
5. Literature Searches