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MDCG 2023-1 - Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Medical devices regulation

Medical devices can be manufactured and used within EU health institutions (in-house devices), on a non-industrial scale, to address the 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. In-house medical devices are exempted from most of the provisions of Regulations (EU) 2017/745 (medical devices Regulation, MDR) and (EU) 2017/746 (in vitro diagnostic medical devices Regulation, IVDR), provided the health institution adheres to the conditions laid out in Article 5(5) of the relevant Regulation. In order to ensure the highest level of health protection, Article 5(5) sets a number of rules regarding the manufacture and use of such in-house medical devices.

The provisions in Article 5(5) are the basis for the regulatory control and oversight of inhouse devices. This document provides guidance on the application of some of these rules. It is written for healthcare professionals and researchers of health institutions aiming to design, manufacture, modify and use in-house devices. In addition, this guidance document intends to foster harmonised application of Article 5(5) by the national competent authorities.

Link to the MDCG guide

Detailled Summary:



  • It focuses on the exemption for medical devices manufactured and used within EU health institutions (termed "in-house devices") to cater to specific patient groups when market alternatives do not meet their unique needs.
  • Such in-house devices are exempt from many provisions of the mentioned EU regulations, provided conditions in Article 5(5) are followed.
  • This document offers guidance on some of the rules in Article 5(5). It's targeted at healthcare professionals and researchers intending to create or use in-house devices. The aim is also to harmonize the application of Article 5(5) across national competent authorities.
  • Exemptions in Article 5(5) apply only to health institutions within the Union. Any entity offering distant medical services to EU patients must use devices compliant with the MDR or IVDR.


  • Recommendations cater to both medical devices and in vitro diagnostic medical devices (IVDs). Specific cases for IVDs are clearly marked.
  • Some provisions for in-house IVDs were deferred by Regulation (EU) 2022/112. The timing for the applicability of IVDR Article 5(5) can be found in Annex B. The MDR's Article 5(5) has been in effect since 26 May 2021.


  • Health institution: Primarily aimed at patient care or promoting public health. This encompasses hospitals and other entities supporting the healthcare system, such as labs and public health institutes. Gyms, spas, and wellness centers aren't covered. The recognition varies based on national laws.
  • In-house device: A device made and used solely within an EU-established health institution, meeting all conditions of Article 5(5) of the MDR or IVDR.
  • In this guidance, the term 'device' adheres to definitions in the MDR and IVDR. Some clarifications:
  • Shared written protocols between health institutions are not devices.
  • Patient specimens are not devices and can be shared.
  • Devices must either be CE marked, manufactured in-house as per Article 5(5), be investigational, or have an exemption.
  • Member states can restrict certain in-house devices.


3.2 Terms 'Manufactured and Used':

  • For Article 5(5) to apply, a device should be both made and used within the same health institution.
  • Manufactured includes creating a device from raw materials or other components, combining devices to form new ones, or modifying existing devices.
  • Used means the device's production and use are confined to health institutions in the Union. The use can be physical or, for software, remote. If the device is used outside the health institution's entity, it doesn't qualify as in-house.

Additional Points:

  • The IVDR and MDR don't typically dictate how healthcare professionals use a device. Still, national regulations might apply when a device is used outside its intended purpose.
  • Devices labeled for research use only aren't governed by the MDR and IVDR. If a health institution assigns a new purpose aligning with the definitions in the MDR or IVDR, Article 5(5) comes into play. In-house devices can contain these products if they adhere to Article 5(5) requirements.

The guidance provides also examples of in-house devices, and non in-house devices.

3.3 Compliance with the relevant general safety and performance requirements

  • Health institutions must ensure that their in-house manufactured devices are compliant with the relevant general safety and performance requirements in Annex I of the MDR and IVDR.
  • It's vital for health institutions to document and periodically update their proof of compliance with Annex I. Any major changes to in-house devices should be evaluated and recorded.

3.4 Definition and Scope of Legal Entity:

  • In-house devices must not be transferred to a different legal entity.
  • The understanding of 'legal entity' may differ due to variations in healthcare systems across member states. Local competent authorities can provide clarification.

3.5 Appropriate Quality Management System (QMS) for In-House Devices

  • Health institutions must utilize an appropriate QMS for the creation and use of in-house devices.
  • The QMS should include a procedure for gathering information about equivalent CE-marked devices entering the market.
  • For MDR, the QMS should comply with specific Articles, Annexes, and ISO standards. It must address areas like compliance, management responsibility, risk management, data analysis, manufacturing processes, traceability, continuous improvement, and communication.
  • For IVDR, laboratories should align with the EN ISO 15189 standard, and the QMS should follow related guidance, addressing areas similar to MDR.

3.6 Justification for Specific Needs

  • Health institutions must detail why market-available devices cannot fulfill the specific needs of a target patient group.
  • The "target patient group" refers to patients with similar medical conditions or needs.
  • Institutions should provide a documented justification for using an in-house device over available market devices. This justification must be periodically reviewed.

3.7 Information Request from Health Institutions by Authorities

  • Health institutions are obligated to provide information about the in-house devices' manufacture and usage to competent authorities when requested. Requested details might include:
  • Device type, purpose, target patient group, and design data.
  • Justification for not using CE-marked alternatives.
  • Manufacturing and modification descriptions.
  • Usage details, including compatibility with other devices.
  • Post-routine use details like production numbers and performance outcomes.
  • Health institutions might also need to notify the authority when an in-house device starts or stops being used or undergoes modification, depending on national regulations.

3.8 Public declaration (IVDR/MDR: Article 5(5)(f)/(e)):

  • Health institutions must provide a public declaration containing their manufacturing details and a statement that their devices meet general safety and performance requirements, as per Annex I of IVDR or MDR.
  • Health institutions should follow potential national guidelines regarding the declaration format, language, and publication conditions.
  • Periodic review and updates of the public declaration are necessary.

3.9 Documentation requirements (IVDR/MDR: Article 5(5)(g)/(f)):

  • Health institutions need to prepare comprehensive documentation detailing the manufacturing facility, process, design, performance data, and intended purpose of their medical devices.
  • This documentation should be clear, organized, and easily searchable, using Annex II of MDR/IVDR for guidance.
  • Updates to the documentation are crucial.

3.10 Vigilance, incidents, and corrective actions (IVDR/MDR: Article 5(5)(i)/(h)):

  • Health institutions must review the clinical experience with their devices and take any corrective actions needed.
  • They should have procedures to collect and process data on device performance, incidents, and corrective actions and refer to national laws for incident reporting requirements.

3.11 Industrial scale:

  • Article 5(5) of both Regulations state that exemptions don't apply to devices manufactured on an industrial scale.
  • There's no fixed definition for 'industrial scale' in MDR or IVDR, but it isn't the same as 'mass-produced'. Factors like production volume, commercial aspects, and the manufacturing process influence this determination.
  • The primary intention is to cater to specific patient group needs, not to produce more devices than needed.
  • In the context of IVDs, analyzing many patient specimens doesn't automatically classify an in-house IVD as industrially produced.

In essence, health institutions must ensure transparency, maintain detailed documentation, continually monitor their in-house devices, and stay within the production constraints to cater to specific patient groups.

Our expertise

Since the arrival of Regulation 2017/745, new requirements have been requested and are part of the documentation to be presented to the notified body.

CSDmed brings its expertise and a methodical approach to its customers, manufacturers, importers and distributors of medical devices, thanks to a team of specialized experts and consultants, who will be able to handle the MDR transition in its entirety.

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