Technical documentation plays a pivotal role in the EU Medical Device Regulation (MDR). It serves as a comprehensive record of the design, development, and performance of a medical device, providing evidence of compliance with regulatory requirements.
Technical Documentation Requirements #
The requirement to draw up technical documentation can be found primarily in Article 10(4) which states:
Manufacturers of devices other than custom-made devices shall draw up and keep up to date technical documentation for those devices. The technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed. The technical documentation shall include the elements set out in Annexes II and III.Regulation (EU) 2017/745 Article 10(4)
The requirement excludes manufacturers of custom-made devices (CMD), however, all other manufacturers regardless of risk classification will be required to draw up the technical documentation as specified in Annexes II and III.
Reviewing Annexes II and III provides the skeleton of your technical file listing the required sections as well as some specifications and requirements on its content. Based on these annexes, below are the typical sections you would expect.
0. Administrative Provisions #
Although not specifically required by the MDR, we typically add Section 0 to organise some additional documentation including:
- Declaration of Conformity.
- Notified Body Cover Letter, Notified Body Agreement.
- EU Authorised Representative Agreement.
- Previous Audit Findings, EU Certificates, ISO Certificates.
1. Device description and specification, including variants and accessories #
Section 1 can be relatively straightforward to put together, as Annex II specifies all the elements required, including:
- Device identification, intended purpose, and specifications.
- Rationale for the qualification as a medical device.
- Device classification rationale.
- Demonstration of the principles of operation.
- Indication of accessories and other products.
- Reference to previous and similar generations
For certain devices, qualification as a medical device can be challenging, especially in borderline cases where the specified intended purpose may be the difference between a medical device and a pharmaceutical product. A detailed comparison to the definition of a medical device, an accessory to a medical device, or an Annex XVI product as found in the EU MDR will demonstrate that your product falls under the EU MDR.
The classification rationale is conducted against the rules of Annex VIII. In our Device Description and Specification document, we would typically quote these classification rules and provide a rationale as to why the medical device (taking into account its intended purpose and mode of operation) meets that rule or not. Based on these results, we would then come to a conclusion on the final classification of the device and the appropriate conformity assessment procedure to apply.
2. Information to be supplied by the manufacturer #
Section 2 contains all information supplied by the manufacturer to the user / patient. This includes:
- Finalised label artwork for the device, sterile packaging, outer packaging.
- Finalised Instructions for Use (IFUs).
- Other User, Installation or Servicing manuals.
- Implant Card.
- Marketing material.
It is important that this section contains all labels and IFUs, in all the respective translations based on where the product is being sold. For language requirements, refer to this resource: https://specculo.com/translation-and-language-requirements-for-medical-device-companies/
Labels and IFU should meet the requirements of the GSPR Chapter III and take into account the relevant harmonised standards.
3. Design and manufacturing information #
This section shall demonstrate how you have designed and manufactured the product, and may include:
- Design and development plan, traceability matrix, design reviews.
- Manufacturing work flow or description of steps, Device Master Record (DMR), process validation reports.
- Identification of all sites e.g. contract manufacturer, steriliser, suppliers list.
Ensure that this information stays up to date and reflects your current documentation as found elsewhere in your Quality Management System. One problem we often notice during audits is that a document has been updated in the Design History File (DHF) but has not been updated in Section 3.
4. General safety and performance requirements #
Demonstrating compliance with the General Safety and Performance Requirements (GSPR) is arguably the most important aspect of your technical file. Why?
Reviewing Article 5(2) of the MDR shows that “A device shall meet the general safety and performance requirements set out in Annex I which apply to it, taking into account its intended purpose.” Failure to do so would result in being blocked from entry into the EU market.
The industry standard method to meeting this requirement is by creating a checklist from the GSPRs identified in Annex I. For each requirement, the manufacturer must identify whether it is applicable or not to their device and providing an adequate justification in the event it is not applicable.
For all applicable items, the manufacturer must demonstrate how they meet that requirement, providing an adequate reference to the precise document / location which could be used for verification. We even suggest that references to Risk Assessment specify which risks have been assessed in relation to that GSPR.
5. Benefit-risk analysis and risk management #
Compliance with the EN ISO 14971:2019+A11:2021 will ensure that you comply with your requirements on risk management. Risk-related GSPRs in Chapter I of Annex I will be duly met. In terms of documentation, one would at least expect the following:
- Risk Management Plan.
- Risk Assessment [Could be split into dFMEA, pFMEA, uFMEA].
- Risk Management Report.
A benefit-risk analysis shall also form part of the of the Risk Management and thus an adequate investigation of the residual risk and clinical benefits provided by the device shall be conducted.
6. Product verification and validation #
Annex II provides just a taste of what Section 6 should include. When we put together these files, we would include the following sections.
6.1 – Pre-clinical Data #
This subsection shall be further broken down (6.1.1, 6.1.2 etc.) to take into account all pre-clinical testing conducted by the manufacturer including, as applicable and not limited to:
- Biological evaluation.
- Electrical and EMC testing.
- Software lifecycle evaluation.
- Usability studies.
- Sterilisation validation.
- Stability and shelf life.
- Performance and safety, including bench testing.
6.2 – Clinical Evaluation #
Clinical evaluation is considered the crown to any technical file and depending on your device, could be 50 to 300+ pages long. But it’s not all about quantity.
Annex II refers to Article 61(12) and Annex XIV for more specifics on the content of the clinical evaluation. Whilst Annex XIV gives a good list of required elements of the Clinical Evaluation Plan, there is much to be desired in terms of the Clinical Evaluation Report.
In general, we split this section up into:
- Clinical Evaluation Plan (CEP).
- Literature Search Protocol (LSP).
- Literature Search Report (LSR).
- Clinical Evaluation Report (CER).
Currently, the state of the art guidance available to develop the above documentation are MEDDEV 2.7/1 rev. 4 and MDCG 2020-13.
In recent years, the development of a robust clinical background and state of the art has become nearly as important as having sufficient clinical data for your device. The state of the art is best described in ISO 14971:2019 (3.28) as the: “developed stage of technical capability at a given time as regards products, processes and services, based on the relevant consolidated findings of science, technology and experience.” This is sometimes referred to as the “generally acknowledged state of the art” and should be developed based on a review of existing literature and resources to determine clinical safety and performance measures which you could use as metrics for your own device.
Clinical data is specifically data generated from the use of the device under evaluation or an equivalent device. Data collected from similar devices on the market cannot be considered as clinical data. Therefore, the presentation of your clinical data must either come from peer-reviewed literature on your device or an equivalent. Data on other devices can be used to determine known risks and develop the clinical background and state of the art.
All in all, the Clinical Evaluation section is a complex document and regulators have very high expectations of its content and the quality of the reporting, especially for higher risk devices.
6.3 – Clinical Investigation (If Applicable) #
Annexes II and III do not specifically address Clinical Investigations, however, we like to add all relevant Clinical Investigation Plans, Reports, and Summaries to a separate section. The clinical investigation shall be in line with the CEP developed and may take into account current gaps in knowledge of the clinical safety and performance of the device.
Documentation requirements for Clinical Investigations are identified in Annex XV and Chapter VI of the MDR.
7. Post-market surveillance #
Section 7 is dedicated to post-market surveillance (PMS) documentation, including the:
- Post-Market Surveillance Plan.
- Post-Market Surveillance Report [Class I].
- Periodic Safety Update Report [Class IIa/IIb/III].
- Post-Market Clinical Follow-up Plan.
- Post-Market Clinical Follow-up Evaluation Plan.
- Summary of Clinical Safety and Performance (SSCP) [Class III / Implantable].
Annex III generally covers the requirements of the post-market surveillance (PMS) technical documentation and gives all specifications required to develop the PMS Plan. On the other hand, following Annex XIV Part B will give you the barebones for developing a PMCF Plan. However, we recommend referring to MDCG 2020-7 and 2020-8 on the content and format of a PMCF Plan and Report respectively.
For the PMS Report and PSUR, you would need to review Articles 85 and 86 respectively for a better idea on their requirements.
Other Documents #
For devices incorporating a medicinal substance having an ancillary effect to the principal intended purpose, the manufacturer is expected to develop what’s known as a medicinal dossier. We wholeheartedly recommend that you review this guidance document.
Preparing Technical Documentation #
In putting together the above technical documentation, we recommend that you strictly stick to the numbering and title structure as presented in theses annexes as it will facilitate review of documentation by Notified Bodies and/or Competent Authorities, as well as other interested parties.
There is no strict requirement in how the documents are formatted, but we recommend a concise and clear approach. If you are preparing the documentation for NB review, they will ignore any vast expanse of introductory text in your documents, so don’t focus on that.
With that said, there’s nothing better than a well-organised, clean and well-documented technical file. The documentation must be searchable and, in some cases, NBs might request that these be bookmarked.
Also, treat your technical documentation as live documents. They’re not something you print out and store in your back-office drawer for 10 years. Risk management is a continuous process feeding into (and being fed into) all other sections of the technical documentation and quality management system.
Keep up to date with the latest guidance and best practices in developing your technical documentation. This allows you to stay ahead of the curve and ensure seamless documentation assessments.
Quality Management System (QMS) and EU MDR #
Many think of the QMS and the technical documentation as two separate entities, when in fact they are intertwined and feed into each other.
Technically speaking, your device’s technical file falls under the Medical Device File requirements. You may also keep templates or forms which you use to develop the technical documentation.
Document and record controls also apply to the technical file, and thus should go through a formal review and approval process whilst also taking into account requirements for their safe retention.
The organisation’s management must ensure that sufficient resources are in place for the continuous development of the technical documentation including, for example, conducting PMCF activities.
Risk management documentation could very easily feed into design control in order to mitigate newly identified hazards and side effects of the device in the field. The subsequent verification and validation documents could then be made part of the device’s technical documentation.
The considerations in Annex IX conformity assessment procedure requires that manufacturers have plans in place to continually monitor and update the CEP taking into account the state of the art. Furthermore, the post-market surveillance documentation described above are all a function of the PMS procedure within the QMS.
Therefore, a healthy quality management system which has been updated in accordance with the requirements of the EU MDR will directly reflect on the quality of the technical documentation and medical device.
Post-Market Surveillance and Documentation #
Although post-market surveillance is not a newly introduced requirement, it has become one of the cornerstones of compliance with the EU MDR. As discussed above, there are various PMS documentation controlled by an overarching PMS procedure.
The intention is that the manufacturer reviews data collected in the post-market phase (at least at planned intervals) and uses this information to improve their device’s safety and performance, if required.
The PMS Plan details which post-market activities shall be conducted, as well as the timelines and responsibilities. This will technically also encompass the PMCF activities to be carried out. Once the data is collected, it is reviewed and reported within the PMS Report or PSUR. Based on the outcomes of these reports, there may be changes necessary in other documentation (typically the Clinical Evaluation and Risk Management sections).
Here are some helpful resources to get you going:
Common Challenges and Solutions #
By far the most frequently encountered issue by Notified Bodies in their initial stages of review is that the documentation provided to them is incomplete. That means that there may be missing documents or basic requirements which are not met. This is a relatively easy problem to fix through a gap analysis comparing the requirements of the EU MDR to your existing documentation.
Another frequent problem is the lack of pre-clinical data such as biological evaluation. The biological evaluation is a critical segment of the technical file, demonstrating that the device is safe when in contact (for whatever duration) with the patient. Putting in place a robust Biological Evaluation Plan and a Toxicological Risk Assessment will be able to determine which testing is required and what can be waived.
Conducting pre-clinical testing such as biocompatibility or stability and shelf life testing is both time consuming and expensive, and this is certainly something which you want to get done before applying with a Notified Body.
However, the biggest obstacle to obtaining a CE mark is the lack of clinical data, or the lack of demonstrating the clinical safety and performance of the device. Whilst collecting clinical data is all well and good, if you cannot present it in the required format then there’s no use arguing with the regulator. If you don’t have any clinical data, and cannot demonstrate equivalence, then you’re going to need to rethink your strategy, especially for Class III and implantable devices.
The recent scrutiny on developing a detailed state of the art and defining clinical benefits has meant that many manufacturers are facing issues in getting their files through the review stages.
The way we go about creating technical documentation is that we start with a strategy and consider all the relevant requirements for that specific device / device type. We get an understanding of the relevant harmonised or international standards and best practices, to be able to determine whether specific pre-clinical testing or additional design inputs will be needed. We present this to our customers for them to get a good idea of an additional requirements which they might need to be aware of and get started with.
Following that, we develop a detailed intended purpose which will be key in putting together the technical documentation. We would then move sequentially between the technical file sections, however, iterating these when needed.
Specculo’s Services for EU MDR Compliance #
Our team is experienced in setting up robust technical documentation for all types of devices. Based on your product, we can evaluate the most appropriate strategy for you and ensure that you meet all the Regulation’s requirements to pass your NB assessments. Head over to our Regulatory Consulting page to find out how we may support your efforts, including:
- EU MDR and IVDR Compliant Technical Documentation.
- EU MDR Gap Assessment.
- EU MDR Internal Audit.
- QMS Consulting.
- Training Services.
Ensure your success with Specculo – Your Trusted Partner in Regulatory Excellence. Contact us today for personalized regulatory consulting tailored to your needs.