Article 5(5) of Regulation (EU) 2017/745 (MDR) provides for a specific regime for certain medical devices manufactured and used within health institutions. Often called the in-house regime, this mechanism allows, under strict conditions, a derogation from certain requirements normally applicable to medical device manufacturers.
This provision targets in particular university hospitals, medical centres, hospital laboratories or specialised institutions that develop or adapt devices to meet the specific needs of their patients when the solutions available on the market do not make it possible to achieve the required level of performance.
Contrary to a widespread belief, Article 5(5) does not constitute a general exemption from the MDR. It is a tightly framed derogation whose conditions must be met on an ongoing basis.
Why does the MDR provide for an in-house derogation?
The European legislator wanted to preserve the innovation capacity of health institutions.
In certain highly specialised fields, notably personalised medicine, rare diseases or certain complex diagnostic applications, institutions may need to develop their own technical solutions tailored to their needs. Imposing on these structures all the procedures applicable to a commercial manufacturer could make such developments impossible or disproportionate.
Article 5(5) therefore seeks to strike a balance between hospital innovation and patient protection.
Which devices are concerned?
The in-house regime may apply to devices manufactured and used within health institutions legally established in the European Union. These devices may be developed directly by the institution or manufactured under its control. However, they must not be transferred to another legal entity or placed on the market within the meaning of the MDR.
As soon as a device is supplied to another organisation or becomes accessible outside the institution’s internal framework, the derogation regime generally ceases to apply.
The conditions of Article 5(5)
The benefit of the derogation regime is subject to several cumulative conditions.
The devices must not be transferred to another legal entity
One of the fundamental conditions is that the devices are manufactured and used within the same legal entity. The aim is to prevent an institution from using the in-house regime to circumvent the rules applicable to the placing of medical devices on the market.
An appropriate quality management system must be in place
The institution must have a quality management system suited to its activities. This system must make it possible to control the manufacture, testing and use of the devices concerned. Even though the MDR does not make ISO 13485 certification mandatory in this context, the competent authorities expect to find documented processes demonstrating control of the activities concerned.
The general safety and performance requirements must be met
The exemption does not remove the obligation to ensure patient safety. In-house manufactured devices must meet the general safety and performance requirements set out in Annex I of the MDR to the extent that they are applicable. The institution must be able to demonstrate that risks are controlled and that the claimed performance is achieved.
The specific needs of patients must be justified
The institution must demonstrate that the specific needs of the target patient group cannot be met, or cannot be met at an appropriate level of performance, by an equivalent device already available on the market. This condition is one of the pillars of the in-house regime. Before developing or using an in-house device, the institution must therefore be able to justify the absence of a suitable commercial solution.
Information relating to use
At the request of the competent authority, health institutions provide information concerning the use of these devices. This information notably includes the justification for their manufacture, the modifications made and the intended use of these devices.
Documentation must be kept available
The institution must draw up documentation describing in particular:
- the device concerned, including its design data and its intended purpose;
- its manufacturing process and the dedicated facilities;
- the expected performance;
- the conditions of use;
- the elements demonstrating compliance with the applicable requirements.
This documentation must be made available to the competent authorities on request.
A public declaration must be drawn up
Article 5(5) also requires the institution to make public certain information relating to the devices concerned, in the form of a declaration. The latter must notably include:
- the name and address of the manufacturing institution;
- the information needed to identify the devices;
- a declaration stating that the devices meet the applicable general safety and performance requirements;
- the identification of any requirements that are not fully met, together with their justification.
A review of the experience gained must be carried out
The institution must review the experience gained from the use of the devices. Feedback, incidents, non-conformities and corrective actions must be analysed in order to continuously improve the safety and performance of the devices concerned.
Vigilance obligations remain applicable
The in-house regime does not exempt the institution from all responsibility after the device is put into service. Serious incidents and identified risks must be managed in accordance with the applicable requirements of the MDR and the national provisions put in place by the competent authorities. Institutions must therefore maintain active surveillance of the devices used under this derogation.
Is the intervention of a notified body mandatory?
Contrary to an idea frequently repeated in certain publications, Article 5(5) does not provide for the systematic intervention of a notified body for these devices, regardless of the class.
Key takeaways
Article 5(5) of the MDR allows health institutions to manufacture and use certain medical devices without following the full placing-on-the-market procedures applicable to commercial manufacturers.
This derogation nevertheless remains strictly framed. The institution must demonstrate that no equivalent solution available on the market meets patients’ needs, put in place a suitable quality system, comply with the general safety and performance requirements, document its activities and ensure continuous monitoring of the devices used.
The in-house regime must therefore be regarded as a regulatory exception intended to meet specific medical needs, and not as a simplified alternative to CE marking.
Regulatory source: Article 5(5) of Regulation (EU) 2017/745 — EUR-Lex