Custom-made devices were already defined in the MDD. The introduction of the MDR has not fundamentally changed this definition, but the MDR has significantly increased the requirements for placing custom-made devices on the market. The main points here are the stricter requirements for documentation, post-market surveillance (PMS) and the obligation to have implemented a quality management system.
Custom-made devices are intended for special cases in which commercially available products or alternative therapies are not sufficient to fulfil the needs and requirements of certain individuals. To understand exactly what regulatory implications apply to custom-made devices, it is helpful to look at the definition provided in the MDR. According to MDR Article 2, 42, a custom-made device is a device “specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional qualifications which gives, under that person’s responsibility specific design characteristics, and is intended for the sole use of a particular patient to exclusively meet their individual condition and needs.”
Custom-made devices are therefore characterised by their particular design specifications, which are usually outlined by qualified personnel on the prescription. This also ensures that this product is indeed only intended for a single patient, but at the same time has a strong individual benefit for that patient. This means that the doctors or other qualified persons authorised to issue a prescription are responsible for the custom-made device and its use.
Despite their exclusivity (custom-made devices are not produced in series), custom-made devices are subject to certain regulatory requirements, such as the general safety and performance requirements, and are regulated in this way to ensure the safety and effectiveness of the medical device.
Custom-made devices vs. adaptations
In contrast to custom-made devices , the group of so-called adaptable devices exists. These are devices produced in series that must be adapted to meet the specific requirements of a professional user and devices that are mass-produced in industrial processes in accordance with the written instructions of an authorised person. Adaptations are further divided into “patient-matched medical devices” and “adaptable medical devices” and do not count as custom-made devices. This is laid down in Article 2, Section 3 of the MDR.
There is often a lack of clarity when it comes to distinguishing between custom-made devices and adaptations. A patient-matched medical device is characterised by the fact that it can be precisely adapted to the patient’s entire anatomy within a specific design framework using appropriate techniques based on the patient’s anatomical characteristics. It is developed by a manufacturer and produced in batches. Only in certain circumstances a doctor or other qualified person is consulted. These include products such as 3D-printed mandibular implants, customised contact lenses or 3D-printed plates for fixing broken bones.
Adaptable medical devices are mass-produced and adjusted shortly before use in accordance with the manufacturer’s validated instructions. This is necessary in order to meet the specific anatomical and physiological characteristics of the patient during use. This product group includes customised wheelchairs, hearing aids and braces.
An even more specialised group within custom-made devices are implantable custom-made devices. At first glance, these are subject to the same regulatory requirements as custom-made devices per se and are also defined in the same way in the MDR. In the case of implantable custom-made devices, however, it is still important that the materials used are biocompatible and acceptable for long-term use in the human body. The requirements for the biocompatibility of medical devices must be taken into account when selecting the materials. Another important point here is surgical implantation and follow-up care, so that complications can generally be avoided and successful integration of the medical device can be guaranteed.
Regulatory pathway: what the MDR requires
Compliance with Annex XIII of the MDR is crucial for the correct placing on the market of custom-made devices. This regulates exactly what information must be provided, how the manufacturing process is controlled and which processes downstream of production are relevant.
The declaration, which must be enclosed with every custom-made device is particularly important and must contain the following information:
- Name and address of the manufacturer and all production sites
- If applicable: name and address of the authorised representative
- Data required to identify the product
- Declaration that the product is intended exclusively for a specific patient (this patient must be clearly identifiable -> name, acronym, code)
- Name of the person who prescribed the product
- Specific features of the product
- Declaration that the product complies with the GSPR
This declaration can be equated with a declaration of conformity, as it provides overall assurance that the general safety and performance requirements have also been met for the custom-made device.
In addition, the other regulatory requirements from Annex XIII are generally somewhat weaker than for medical devices that are produced in series and are not considered custom-made devices. Although the manufacturer must prepare and update the entire technical documentation, this must only be made available to the competent authorities on request.
The exemption from the UDI obligation is a major relief. In this context, it is often mentioned that no CE mark has to be affixed, as no classic EU declaration of conformity is issued. Manufacturers merely carry out the simplified procedure for conformity assessment in accordance with Annex XIII and draw up the declaration in accordance with Section 1 of the aforementioned Annex, with the information already set out above, before placing the devices on the market. This declaration must also be made available to the patient, who is clearly identifiable either by name, an acronym or a numerical code. It is therefore also very important for labelling and general marking that the product bears the words “custom-made device”.
However, manufacturers of class III implantable custom-made devices are required to follow the conformity assessment procedure set out in Annex IX, Chapter I, or alternatively to carry out a conformity assessment in accordance with Annex XI, Part A.
Where there are simplifications in some areas, the regulations remain strict in others. For example, manufacturers of custom-made devices also need a PRRC (Person Responsible for Regulatory Compliance) in accordance with Article 15, although there are a few restrictions in terms of the nature of the activity and the requirements for the qualifications of this person. Without prejudice to national legislation on professional qualifications, manufacturers can demonstrate the expertise required in subparagraph 1 through two years of professional experience in the relevant manufacturing sector. In this case, the PRRC does not have to be registered in the EUDAMED.
For the post-market surveillance aspect, a report must be prepared for Class I devices and a Periodic Safety Update Report (PSUR) for all other classes in accordance with the requirements of the MDR. These reports are also part of the general documentation for the custom-made device. However, the PSUR does not have to be submitted to the Notified Body for Class III devices. A Summary of Safety and Clinical Performance (SSCP) does not have to be issued.
In addition, the PMS process is carried out without further restrictions, as described in the MDR. This also applies to the PMCF, risk management and clinical evaluation, which are generally part of the QM system and are therefore also required for custom-made devices.
Obligations as a manufacturer
The manufacture of custom-made devices must take place within the framework of an established quality management system. Manufacturers must fulfil the requirements for QM systems in Article 10(9) of the MDR. In this context, it must be ensured that the conformity of the manufactured custom-made device with its documentation is guaranteed during the manufacturing process. This also guarantees monitoring throughout the entire manufacturing process.
In addition to naming the manufacturing site, the documentation must also contain information describing the design, manufacture and intended performance of the device so that it can be assessed whether the custom-made device complies with the requirements of the MDR. In addition, the requirements of the respective countries in which the custom-made devices are placed on the market must also be observed. The documentation also includes the written certification of the person authorised to issue it, including all templates, models or impressions required for the custom-made device for the design and characteristics of the product. This is particularly important in order to demonstrate that the custom-made device is manufactured according to the individual condition or individual needs of the named person. This fulfils an additional documentation obligation specifically for custom-made devices and these efforts are intended to contribute in particular to the transparency and traceability of the product.
For implantable custom-made devices, all documents must be retained for at least 15 years or for the period of the intended product life cycle. For all other custom-made devices, documents must be retained for at least 5 years or for the intended product life cycle, whichever is longer.
Examples of custom-made devices
Manufacturers who work as dental technicians, orthopaedists or opticians are likely to be most affected by the MDR’s amended requirements for custom-made devices. As the distinction between adaption and custom-made device ultimately always remains very narrow, we provide the following specific examples after presenting all the requirements for custom-made devices to differentiate them from other medical devices:
- Hand prostheses that are intended to replace a lost body part and/or a lost function of a body part and that are manufactured according to a written prescription. The doctor must provide patient-specific characteristics that must be taken into account during the design and subsequent manufacture.
- Dental crowns that are manufactured according to a dentist’s written prescription and implement specific design features for the patient’s individual condition.
- Orthoses that are manufactured in accordance with a written prescription, taking specific features into account, in order to provide relief for a patient with a neuromuscular or musculoskeletal impairment of the lower extremities. These include knee-ankle-foot orthoses.
In addition, healthcare facilities with an affiliated workshop may also fall under the regulations on custom-made devices. Article 5(5) of the MDR sets out a number of requirements in this regard. However, a precise distinction must be made as to whether it is a custom-made device or an adaption. In any case, the basic safety and performance requirements must also be demonstrably fulfilled, and a publicly accessible declaration must be created for the respective product.
Further input for manufacturers of custom-made devices
Custom-made devices, tailored to the individual needs and characteristics of individual patients, represent a significant advance in medical technology. In addition to the pure legal text of the MDR, there are also further guidelines from the IMDRF and the MDCG to support the development and regulation of custom-made devices.
The IMDRF guidance document “Personalised Medical Devices – Production Verification and Validation“, which was published in April 2023, is a technical guideline that addresses the aspects of verification and validation of patient-matched medical devices in more detail on the one hand and the technical considerations of a medical device production system (MDPS) on the other. It is an important step that uniform and harmonised requirements for custom-made devices have been adopted, thus offering advantages for manufacturers, users, patients and regulatory authorities.
In addition, the MDCG Guidance Document 2021-3 is also very useful. It is designed in a question-and-answer format and focuses on custom-made devices, considerations for adaptable medical devices and patient-matched devices. It adheres to the guidelines and terminology of the MDR and the IMDRF document and addresses the most relevant questions on the topic of custom-made devices. As a manufacturer of custom-made devices, it is therefore worth taking a look at this guide!
If there are still unanswered questions for your case, we will support you in implementing effective processes for the manufacture of custom-made devices, carry out GAP analyses and advise you on the initial implementation of new processes.
Our approach is comprehensive and takes all relevant factors into account. By working closely together, we jointly pursue the goal of a sustainable and long-term solution for the problem-free production of your custom-made device and its delivery to the patient.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.
