In-House Medical Devices: Understanding the Regulatory Framework and Compliance Requirements under European Regulations (EU) 2017/745 and 2017/746

The European Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR), concerning medical devices and in vitro diagnostic medical devices respectively, introduced stricter requirements to ensure the safety and performance of devices on the European market. Among these provisions are specific rules for so-called “in-house” medical devices, which are manufactured or modified by health institutions (entities contributing to patient care, treatment, and/or public health efforts) for internal use. These devices benefit from a derogatory regime compared to industrially-manufactured devices but are nonetheless subject to strict conditions to ensure their quality and safety.

This article explores the applicable rules, documentation, compliance requirements, as well as the specificities of these devices.

1. In-House Medical Devices: Regulatory Framework

“In-house” medical devices are defined by their specific nature: they are manufactured or modified and exclusively used within the same health institution. These devices address specific needs of target patient groups which cannot be met or cannot be met at the appropriate level of performance, by an equivalent CE-marked device available on the market. For example, a research laboratory within a hospital could develop a specialized in vitro diagnostic device to diagnose a rare disease for which no in vitro diagnostic device is available on the market to perform this diagnosis.”

Article 5(5) of MDR and IVDR establishes an exception to the general principle that medical devices must bear a CE mark before being placed into service. It allows health institutions to manufacture and use these “in-house” devices, regardless of their classification, without CE mark, provided that strict requirements are met. However, this exception must not be used to bypass the CE certification processes or for purely economic reasons.

A clear distinction must be made between “in-house” medical devices and custom-made devices. Custom-made devices are defined as devices specifically manufactured according to a written prescription by a person authorized under national law based on their professional qualifications, specifying, under their responsibility, the unique design characteristics, and intended solely for use by a specific patient and exclusively in response to the patient’s individual health needs and condition. Unlike “in-house” devices, custom-made devices are intended for exclusive use by a single patient while remaining subject to a distinct regulatory framework and falling outside the scope of Article 5(5) of the regulations.

2. Provisions under Article 5(5)

To benefit from the derogatory regime set out in Article 5(5) of MDR and IVDR, “in-house” medical devices must meet several cumulative conditions:

a) Internal Manufacturing and Use: : The medical devices must be manufactured and used exclusively within the same health institution. They cannot be transferred or distributed to other legal entities, including other health institutions.

A health institution is defined as an organization primarily focused on treating or caring for patients or promoting public health. This includes hospitals as well as other institutions, such as laboratories and public health institutes, that support the healthcare system and/or address patient needs, but which do not treat or care for patients directly.
However, organizations primarily engaged in health interests or lifestyle activities, such as gyms, spas, wellness centers, or fitness centers, are excluded. The recognition of an organization as a health institution may also depend on national legislation, meaning this definition can vary between European Union (EU) Member States.

b) Absence of Equivalent Devices on the Market: The health institution must demonstrate that no equivalent medical device capable of meeting the specific needs of the target patient groups is available on the market.

c) No Industrial Production: In-house medical devices must not be manufactured on a large scale or for commercial purposes.

d) Compliance with General Safety and Performance Requirements (GSPR): While “in-house” medical devices are exempt from CE marking, they must comply with the General Safety and Performance Requirements (GSPR) outlined in Annex I of MDR and IVDR. These requirements encompass aspects such as design, manufacturing, materials used, associated risks, clinical performance, and identification.

e) Documentation and Notification to Competent Authorities: Health institutions must maintain comprehensive documentation justifying the absence of equivalent alternatives and demonstrating that the in-house device meets specific needsof target patient groups. This documentation, which includes information on the manufacturing, modification, and use of the devices, must be accessible to competent authorities, who may request its review or conduct inspections to verify compliance.

It is worth noting that, unlike commercially available medical devices, healthcare institutions are not required to register “in-house” devices in the European Database on Medical Devices (EUDAMED).

If any of the above conditions are not fulfilled or the GSPR cannot be satisfied, the medical device cannot benefit from the provisions of Article 5(5). In such cases, this regulatory pathway becomes inapplicable. Several alternatives can be considered to make a medical device or in vitro diagnostic medical device available or usable:

• Obtain CE mark to certify compliance with European regulations.
• Consider use within the framework of clinical investigations (for medical devices) or performance studies (for in vitro diagnostic devices).
• Limiting the use of in vitro diagnostic medical devices to “research use only” without direct medical purposes.

3. Practical Implementation of Article 5(5)

To ensure regulatory compliance and the safety of in-house medical devices, health institutions must adopt a rigorous approach, which includes:

a) Implementation of a Quality Management System (QMS): Establishing a QMS is essential to ensure that in-house devices meet appropriate standards and regulatory requirements, including compliance with the GSPR outlined in Annex I of the regulations. This QMS should cover all stages of the device lifecycle, from design to use, including manufacturing and clinical monitoring. Standards such as EN ISO 13485, as well as the provisions of Article 10(9) of MDR or Article 10(8) of IVDR and the MDCG (Medical Device Coordination Group) guidelines, can be used as references to structure this system effectively.

b) Detailed Documentation and Transparency: Documentation must be comprehensive and accessible to competent authorities. It should include all necessary information to demonstrate compliance with the GSPR, such as:

• Evidence of the absence of equivalent devices on the market. The health institution must have a thorough understanding of the market and be able to demonstrate this, ensuring that no equivalent device, even custom-made, is available to meet its needs.
• This requires the health institution to conduct scientific and regulatory monitoring.
• A clear justification for the manufacturing, modification, and use of the devices.
• Detailed information about the manufacturing facilities, processes, design, technical characteristics, and performance.A description of the specific clinical needs addressed by the devices.

c) Creation of a Public Declaration: The health institution must prepare a public declaration, which should include:

• The name and address of the manufacturing health institution.
• Details necessary to identify devices (product name, product code or reference, description, or any other unambiguous identifier allowing the device to be identified, and its intended use).
• A declaration that the devices meet the GSPR. If certain requirements are not met, a justified explanation must be provided.

Healthcare institutions must review applicable national legislation, rules, or guidelines concerning the exact format of the declaration, language requirements, and fulfil publication conditions (e.g., publication on the healthcare institution’s website and/or on a dedicated webpage managed by the competent authority). A template for the public declaration is provided in Annex A of the MDCG 2023-1 guidance document.

d) Conform Manufacturing and Corrective Measures: The health institution must ensure that in-house devices are manufactured in strict compliance with the established documentation, with active management involvement and resource allocation.

• In case of non-conformity or identified risks, corrective measures must be implemented immediately. To achieve this, the institution may adopt the following actions:
• Establish a comprehensive traceability system for in-house devices, including labeling and identification, to ensure effective management of products, patients, and available market devices.
• Develop a continuous improvement plan to reduce risks associated with device use.

e) Clinical Surveillance System: A structured, continuous, and systematic clinical surveillance system must be implemented to collect data on the use of in-house devices. This data allows for:

• Identifying potential incidents or issues related to their use.
• Taking corrective measures to improve safety and performance, if necessary.
• Regularly updating risk management and clinical performance data.

4. Specificities of In-House In Vitro Diagnostic Devices

In-house in vitro diagnostic medical devices are subject to additional requirements, including compliance with EN ISO 15189 Medical laboratories — Requirements for quality and competence or, where applicable, national accreditation provisions. This standard, designed for medical laboratories, establishes a rigorous framework to ensure reliable, accurate, and reproducible results while meeting the needs of patients and health professionals.

Furthermore, for Class D in vitro diagnostic medical devices, documentation requirements for understanding manufacturing facilities, processes, design, and performance data are mandatory. Member States may also apply these provisions to Class A, B, or C devices, in accordance with the rules set out in Annex VIII of IVDR.

Unlike Article 5(5) of MDR, which has been applicable since May 26, 2021, Article 5(5) of the IVDR benefits from a transition period, with all provisions of article 5(5) being applicable as of 26 May 2028.

5. Key Takeaways on In-House MD and IVD

In-house medical devices are a valuable solution for health institutions, enabling them to address a target patient group’s specific needs not covered by existing treatments or devices. This flexibility is made possible by Article 5(5) of Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). These provisions allow health institutions to manufacture, modify, and use these devices without CE mark, provided they adhere to a strict regulatory framework.

In cases where this framework cannot be adhered to, health institutions must instead follow the requirements for CE marking under MDR and IVDR, conduct clinical investigations or performance studies, or limit the use of in vitro diagnostic medical devices to a research-only context.

However, this flexibility comes with heightened responsibilities for health institutions, particularly in terms of documentation, quality management, traceability, and oversight by competent authorities. These regulations underscore the EU’s commitment to ensuring the safety and performance of medical devices while recognizing the unique needs of health institutions and patients. As the regulatory landscape continues to evolve, it is essential for health institutions to stay informed and implement robust systems to ensure compliance and safety for in-house medical devices.

Need help?

To support health institutions in this process, our experts offer tailored services, including:

• Training on the requirements imposed by Regulation (EU) 2017/745 and Regulation (EU) 2017/746 in the context of in-house devices.
• Implementation of a quality management system.
• Drafting compliance documents to meet the requirements of Annex I of the regulations.
• Preparing the public declaration.
• Communication with competent authorities.
• Clinical surveillance and management of corrective actions.
• Hotline assistance to address your questions and provide guidance on specific topics.

For any assistance or to learn more about our services, please contact us at: TechnicalDivision@efor-group.com