Anna Szczepkowska
Consultant, Medical Device QA
Technical documentation, also known as technical file, is a set of the documents that contains all the technical information concerning a medical device. Therefore, every EU manufacturer of medical devices (regardless of risk class) must according to regulations create technical documentation. This must include clear information regarding design, manufacture, and operation of the device.
The journey manufacturers need go through to meet regulatory requirements – and get the CE mark – is often very complex. An example of this process is presented in Figure 1 below.
In this article, we will focus on the MDR requirements. The MDR (Medical Device Regulation 2017/745) replaces MDD (Medical Device Directive 93/42/ECC). For MDD devices already on the market the transition to MDR is often described as “demanding” and “expensive”. However, it is good to keep in mind that by creating a well-planned regulatory strategy and preparing the technical documentation “as good as possible from the beginning” can facilitate a smooth process.
Figure 1. The process of the device launching
A manufacturer of the medical device is obligated to:
The technical documentation must show that the medical device conforms to applicable regulatory requirements such as MDR. Which therefore ensures that the medical device is safe and effective.
Key components of the technical documentation are specified in Annex II and Annex III in the MDR and “shall be presented in a clear, organized, readily searchable and unambiguous manner” (Annex II, point 1.1.1 (a)):
Annex II – Technical Documentation
Annex III – Technical Documentation on Post Market Surveillance
As mentioned above, the technical documentation preferably presents as clear, organised, and unambiguous. Also, following applicable standards and guidelines increases the probability of good technical documentation which is easy to maintain. The Notified Body, which the manufacturer has a signed contract with, usually prepares a technical guidance with clear instruction on how the technical documentation should be submitted. To follow this guidance can increase the speed of the Notified Body review. The support of an experienced person, for instance a consultant, can enable this process. Since the technical documentation is often considerable, the choice of storage is important. Using an electronic signing and storage solution can save a lot of time. It can also improve the possibility of maintaining the technical documentation up to date during the device’s entire life cycle.
A common challenge is estimating the time and resources needed for a Notified Body submission. Project planning, as well as having available resources to answer the Notified Bodies questions, play a crucial role to get approval and getting the device on the market. The support of an experienced person, for instance a consultant can enable a smooth process.
As presented, the preparation of technical documentation is a requirement that needs to be fulfilled to place a device on the European market. Once it is done, it is important to keep the technical documentation up to date according to the latest regulations. Compared with the MDD requirements, the expected quality of the technical documentation has increased in conjunction with the MDR transition. The inclusion of the PMS requirements, according to Annex III of the MDR and stricter requirements on clinical data, mean that manufacturers must improve the scientific quality of technical documentation. At Key2Complaince, we will help you every step of the way when creating a technical documentation, and also keeping it up to date.
