“What has not been documented does not exist” is a statement often made by auditors in the context of quality management systems. This is also true for all activities concerning the conformity assessment and the entire life cycle of your medical device! The preparation of the technical documentation is mandatory for each manufacturer according to Art. 10 (4) of the new EU medical device regulation (EU MDR). What has changed in comparison to the former EU directives? And more important: how can you generate added value for your company by creating a new or revising an existing technical documentation?
- Why Do You Need a Technical Documentation?
- What Does the Technical Documentation of Your Product Have to Contain?
- Technical Documentation as a Complex Project
- PLM and OEM – a Special Relationship Also Regarding Technical Documentation
- Our Recommendations
Why Do You Need a Technical Documentation?
To put it simple, by May 26, 2020 you need the technical documentation to prove that your product meets the respective requirements of the EU MDR (Art. 10 (4), Annexes II and III). Moreover, the standard ISO 13485 for medical device quality management systems also requests the so-called “Medical Device File” which is in fact the technical documentation.
Th technical documentation of your medical device plays an important part during the conformity assessment by your notified body. But also as part of the monitoring of the notified bodies by the competent authorities the technical documentation of single medical devices is randomly accessed (Art. 45 EU MDR).
What Does the Technical Documentation of Your Product Have to Contain?
Content and structure of the technical documentation are given in Annexes II and III (EU MDR).
Annex II divides the technical documentation into 6 parts in which you essentially answer the following questions:
- What kind of medical device do you have? You characterize the medical device in detail and this part contains, if applicable, also the history of the device. A new requirement is the inclusion of the basic UDI-DI in technical documentation for the traceability of the medical device.
- What information do you provide with your medical device? You provide here the instructions for use and labels containing essential information of the operation of the medical device.
- How did you design and how do manufacture your medical device? You provide here documents derived from the design and production processes.
- How do you meet the requirements of Annex I EU MDR? Due to the changes in the general safety and performance requirements, you can expect considerable additional effort when preparing the technical documentation – even if it already exists in the form required by the EU MDD.
- How do you manage the risks of your medical device? Typically, you include here the risk analysis as well as the risk management plan and report.
- How do you prove the conformity of your medical device by carrying out tests and studies? Provide here descriptions, reports and evaluations of all tests and studies carried out for your medical device.
Additional Help Needed?
If you need more detailed information on the content of the technical documentation check out the following documents:
- Recommendation NB-MED/2.5.1/Rec5 issued by the European Association for Medical Devices of Notified Bodies (TEAM NB) in 2010. Although this recommendation is based on the EU MDD you will still find interesting details in the document.
- Table of contents for “use when filing medical device submissions to regulatory authorities for market authorization” published in 2018 by the International Medical Devices Regulators Forum (IMDRF).
Extension of the Technical Documentation Across the Life Cycle
The technical documentation has always been a “living” document, but now the EU MDR requirements extend over the entire life cycle. Annex III EU MDR therefore requires further contents of the technical documentation, namely, the:
Note, that the technical documentation must be provided in a “readily searchable” format. This can be, for example, a searchable PDF file or a database.
Are There Special Requirements for Software Regarding the Technical Documentation?
Yes, section 6.1. (b) of Annex II EU MDR in general requests information on
- test design,
- complete test or study protocols,
- methods of data analysis,
- data summaries, and
- test conclusions.
In the case of software this is further specified as “summary results of all verification, validation and testing performed both in-house and in a simulated or actual user environment prior to final release”. This usually includes:
- the description of the development process (i.e. according to IEC 62304) and
- the design (i.e. according to IEC 62304 and IEC 62366-1) as well as
- the reports of all verification, validation and test activities.
Moreover, information about hardware configurations and operating systems shall be given as it is usually also done in the instructions for use.
Technical Documentation as a Complex Project
No matter whether you must adapt the technical documentation of your medical device to the new requirements of the EU MDR or must prepare it completely new, consider the numerous internal and external stakeholders.
Internal Stakeholders Must Efficiently Work Together
If you take Annex II as a basis, it becomes clear which internal departments you must involve in the creation and further development of the technical documentation.
For such an important project in the company the management and the human resources department must be involved. Only by this you can ensure the provision of enough budget and staff resources.
The management of the project “technical documentation” may be assigned to the person responsible for regulatory compliance. This staff member is anyway in charge for preparing and updating the technical documentation in accordance with Art. 15 (3b).
Requirements of External Stakeholders Must Constantly Be Monitored and Analyzed
Especially due to higher risk classes for stand-alone software and also other medical devices, there is an increased involvement of notified bodies in the conformity assessment. For each class III product, the technical documentation must be reviewed by the notified body. In the case of class IIb, at least random control of the technical documentation must be carried out by the notified body. In addition, there is a lower number of notified bodies that will be available in the future. Therefore, you are strongly advised to contact your notified body regarding all aspects of the technical documentation as soon as possible.
The implementing legislation and technical specifications stipulated in the EU MDR can also have an (indirect) influence on the technical documentation in many places. Thus, it is absolutely required for your project team to constantly monitor any changes in this respect.
Finally, be aware that you need to have access to all information of sub-contractors or suppliers that is relevant for the technical documentation. Make appropriate contractual agreements.
This project gives you the chance to analyze all interfaces of the product value chain in your company. Moreover, it allows you to optimize the corresponding processes. On the long run this will be a competition advantage!
PLM and OEM – a Special Relationship Also Regarding Technical Documentation
Do your company market a medical device as a manufacturer and has neither developed nor produced it itself? Then your company is a private label manufacturer (PLM). Your company has contracted an original equipment manufacturer (OEM) for manufacturing and assuring quality. PLM and OEM have different responsibilities:
- the PLM assumes responsibility as a manufacturer according to medical device law and
- the OEM is responsible for developing and manufacturing the product (including intellectual property).
As a PLM, you previously had to perform a conformity assessment of the product. The know-how-relevant part of the technical documentation remained with the OEM. The OEM has contractually agreed to make the technical documentation available only to the notified body.
However, as early as 2013, the EU Commission issued a recommendation to the notified bodies clarifying in Annex II that manufacturers (including PLM) must have the technical documentation available themselves and must not refer to the technical documentation of the OEM. It will no longer be possible in the future to “share” the technical documentation between PLM and OEM. Unfortunately, the EU MDR does not contain any clear regulations in this respect. Therefore, various approaches are currently under development.
- Set up a “technical documentation” project considering all internal and external stakeholders. Ensure to have enough personal and financial resources.
- See this project as an opportunity to streamline your internal processes and to optimize the marketing of your medical devices.
- Check whether your product still within the scope of your notified body and get early in touch concerning your technical documentation.
- Monitor the implementing legislation and the technical specifications of the EU Commission for their impact on the technical documentation. Also, check the opinions of Team-NB, the association of European notified bodies in the medical devices sector, on a regular basis.
- Consider the extended storage time of 10 years for the technical documentation and take care of a safe storage place.
We thank Mrs. Isabella Lehner (Croma Pharma GmbH) for helpful comments.