All manufacturers of medical devices need to fulfill the requirements of the MDR (Article 5 and Article 10 (9)). Your case is a bit more special because a hospital developed and uses a medical device. The software drives clinical decision making based on individual patient data. Sounds clearly like a medical device according to Article 2 of the MDR š
In the eyes of the MDR a hospital is a āhealth institutionā. The MDR defines this as āan organisation the primary purpose of which is the care or treatment of patients or the promotion of public healthā. Like hospitals, doctor`s offices or laboratories.
Health institutions benefit from significant exemptions
Luckily, you to follow the complete MDR – actually you only need to fulfill the GSPR checklist, create some SOPs and statements. Let’s take a walk through Article 5 and MDCG 2023-1 on in-house devices.
Side note: The MDR does not define the term āin-house deviceā – believe it or not – and is synonymously used with the term ādevices manufactured and used within health institutionsā. I will use the term āin-house deviceā because it is shorter and everybody understands it instantly.
Second side note: This article is applicable to IVDs and MDs since concepts and requirements are basically the same. Even the guidance combined both regulations.
Article 5 – Placing on the market and putting into service
Subparagraph 5 of Article 5 describes the framework for devices manufactured and used within health institutions. The following chapter is probably the most boring and technical article I ever wrote. I just list the subparagraphs and provide background information from the MDCG 2023-1 plus my best practices. I hope it helps! š
| Article 5 | What it means in normal language | Potential SOP/Technical Document |
| With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices, manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met: | If you meet the following points you only need to comply with the GSPRs. Dumb the rest of the MDR/IVDR. | Download the GSPR Checklist and fill it out. |
| (a) the devices are not transferred to another legal entity, | Don`t walk around and sell the device to another economic operator. | N/A |
| (b) manufacture and use of the devices occur under appropriate quality management systems, | The QMS should be in compliance with Article 5(5), the relevant requirements of Annex I, national legislation and applicable ISO-standard(s) if the health institution is certified/accredited.Article 10(9) of the MDR describes the minimal aspects that a QMS for manufacturing CE-marked medical devices should cover. This Article can be used as guidance (with some MDR-specific exceptions) on what an appropriate QMS for manufacturing in-house devices is. If applicable, ISO-standards concerning for instance manufacturing and risk management can be used, especially if harmonized with the MDR | –SOP Risk Management –Declaration on compliance with the GSPRs -SOP Management -SOP Clinical Data -SOP Manufacturing -SOP Traceability –SOP Improvement -SOP Communication For detailed information check chapter 3.5.1 of MDCG 2023-1. |
| (c) the health institution justifies in its documentation that the target patient group’s specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market, | Write a statement that your device is unique, no other manufacturer can support the needs of your institution and no other device is so beneficial for the patient like yours. | -Statement |
| (d) the health institution provides information upon request on the use of such devices to its competent authority, which shall include a justification of their manufacturing, modification and use; | Add a subchapter to the above mentioned statement and describe that your institution is competent enough to manufacture an in-house device. | N/A |
| (e) the health institution draws up a declaration which it shall make publicly available, including:(i) the name and address of the manufacturing health institution;(ii) the details necessary to identify the devices;(iii) a declaration that the devices meet the general safety and performance requirements set out in Annex I to this Regulation and, where applicable, information on which requirements are not fully met with a reasoned justification therefore, | Download MDCG 2023-1, scroll to Annex A, fill out the template. Hand it out if someone asks. | -Public declaration |
| (f) the health institution draws up documentation that makes it possible to have an understanding of -the manufacturing facility, -the manufacturing process, -the design and performance data of the devices, including the intended purpose, and -that is sufficiently detailed to enable the competent authority to ascertain that the general safety and performance requirements set out in Annex I to this Regulation are met; | Okay, describe how you manufacture the device, how the device performs and show me an intended purpose statement. Show me the GSPR Checklist. | –GSPR Checklist –Intended use statement –Description of manufacturing facility and process |
| (g) the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to in point (f), and | The management makes sure the device is manufactured according to Annex I and that you can show the documentation listed in the paragraph above. | –SOP Management -GSPR Checklist |
| (h) the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions. | Someone reviews the performance and makes sure that corrective actions are managed. | -SOP Management –SOP CAPA -Management report |
| Member States may require that such health institutions submit to the competent authority any further relevant information about such devices which have been manufactured and used on their territory. Member States shall retain the right to restrict the manufacture and the use of any specific type of such devices and shall be permitted access to inspect the activities of the health institutions. | Cooperate with the competent authorities. | Write nice letters and communicate openly š |
| This paragraph shall not apply to devices that are manufactured on an industrial scale. | āIndustrial scaleā is not synonymous to āmass-producedā. A mass-produced medical device is defined in the IMDRF/PMD WG/N49:2018 document as a medical device that is based on standardised dimensions/designs; that is not designed for a particular individual; and that is typically produced in a continuous production run or homogenous batch.In case of IVDs, the analysis of a large number of patient specimens does not automatically render an in-house IVD to a device produced on an industrial scale. | N/A |
Summary
The MDR overregulates a lot but in case of health institutions the job is done well. You do not need to certify the QMS, no need to interact with a Notified Body (yeah), no need to appoint a PRRC, no clinical evaluation (gosh), no (real) PMS… So that takes already a lot of pain from the (overworked) people in hospitals and laboratories. Great!
Generally speaking, I really recommend reading the MDCG 2023-1 for more background information. Especially in order to understand the responsibilities of the management and the regulatory statements.
