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Due the ingenuity of their staff, any local councils and hospitals find themselves in a situation where they are considered a “medical device manufacturer”. With their close patient contact, medical professionals and case workers observe first-hand the needs of their patients and clients on a daily basis. They experience the problems and strive to find patient-centric solutions to improve the lives of their patients and their own work conditions.

Sometimes these solutions are proactive and include the development of new products or the alteration and customization of existing ones. In other cases, reburbishment or maintenance practices have an important affect on existing medical devices.

RAQA can advise and assist in both of these situations, so your council or hospital doesn’t end in an unfortunate liability situation.

In-house Development

The development of new products or the alteration of existing ones can put local councils and hospitals at risk, despite their best intentions and positive impact. In both situations, the council or hospital are legally considered “a medical device manufacturer”.

Together we can review the clinical need that has been established and the practices that have been implemented. Then we work to classify or categorize the product type and look at the applicable regulations and legislation. Equally important, we establish a rational of which regulations and rules are not relevant.

Once all of these parameters are established, RAQA can guide your through the regulatory process, providing the level of assistance you require to gain approvals for your product.

Refurbishment and Maintenance

Many daily medical products, such as wheelchairs and hospital beds, require regular maintanance. Frequently, they also require adjustment (partially or fully refurbished) for another purpose or user. Even products like decision making programs and software are often customized in some aspect.

However, these changes and alterations may not be within the manufacturers specifications. This can lead to new areas of responsibility and liability.

Let us help you differentiate between refurbishing and maintenance, so your organisation is prepared. 

“We are often asked by the councils to adjust a daily living aid for an individual citizen, but we could see that we were at a high risk of becoming a medical device manufacturer.

RAQA helped us find out how to best serve citizens while respecting the manufacturer’s risk assessment concerning materials and specifications (e.g. how much weight can it bear, where the tipping point is, etc.).”

- Technician, Equipment Repair Contractor

Municipalities and hospital sector
“Sometimes councils and hospitals just need a little help in understanding the MDR and other requirements. A little help can go a long way.”

We hear your concerns

Like many public institutions, we weren’t aware that there are EU regulations that cover all medical products. It is a surprise that these regulations are not only relevant for commercially available products, but also include products designed and used exclusively in-house.

Most of the departments that we work with have an in-depth clinical understanding and have made many decision while developing their product. This knowledge and the basis of every decision needs to be written and documented in an MDR-approved format.

We can offer advice or assist in drafting most documents for you. In addition, we will teach your staff the requirements and process, so that they can continue maintaining the documentation in the future.


The thought-process behind the MDR is so different to ours and conflicts with our patient-centered approach.

RAQA can help you understand the terms and intentions behind the regulations, so that you can maintain your patient-centered focus and also fulfil the regulations.

We help make it relevant and understandable for all parties.


The consequences of specific actions (or inactions) are unclear.

For the most part, we have noticed that hospitals and councils have “gone under the radar” and avoided being audited by regulatory boards. But to be on the safe side, RAQA can help you identify the consequences of not complying to the regulation and suggest relevant and realistic steps to guide you in the right direction.


Resources in the field are difficult to come by.

Agreed! Regulatory affairs requires a unique skill set, but we can help you identify the skills and interest amongst your current staff, so that you can help invest in and develop the skills in-house. And where there are gaps in expertise or a need for extra hands, RAQA can assist as needed.

“Sometimes councils and hospitals just need a little help in understanding the MDR and other requirements. A little help can go a long way.”

Services we commonly provide

Project Management

Project Management

  • Establishing and implementing a maintenance system
  • Liasing with manufacturers
  • Coordinating exchange of information between the hospital or council and medical device manufacturers, importers, distributors, and authorised representatives
Process Implementation

Process Implementation

  • Scoping, drafting and executing relevant documents or procedures
  • Teaching requirements and processes, for ongoing maintanance of documentation
Personalized advising


  • Helping locate documentation from manufacturers, importers, distributors or authorised representatives
  • Navigating regulations and “grey areas” of responsibility
  • Establishing a risk-based approach to evaluate maintenance, repairs, and different levels of refurbishment

In addition to the services mentioned above, we provide a wide variety of assistance to hospitals and the public sector with regards to understanding and navigating medical device regulations.

Visit our Regulatory Affairs page to learn more.



Frequently asked questions from Councils & Hospitals
Where can I find the MDR?

The MDR (2017/745) can be found on the EUR-LEX webpage.

Here is a link to the latest version (as of March 20, 2023): eur-lex.europa.eu

We recommend that you use Chrome, as it is optimized for that browser.
Please note: we will strive to keep this link updated, but cannot guarantee that it will always lead to the most current version.

Where are the requirements written for in-house devices?

For in-house products, i.e. a device that is made and used in a single department, the requirements are found in Article 5(5) of the MDR:

5.  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:

(a) the devices are not transferred to another legal entity,
(b) manufacture and use of the devices occur under appropriate quality management systems,
(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,
(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;
(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 therefor,
(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;
(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
(h) the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions.

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.

This paragraph shall not apply to devices that are manufactured on an industrial scale.

Are there any guidance documents for in-house products?

Yes, one was published in January 2023. It is called MDCG 2023-1: Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746.

You can find it under the In-house Section of the MDCG guidance documents: health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en

If we adjust or adapt a product for a patient, are there any consequences with regards to MDR regulations?

That depends on several factors. Article 16(1) states that:

"The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in point (30) of Article 2, assembles or adapts for an individual patient a device already on the market without changing its intended purpose."

For this to be determined, there are three important questions to answer:

  1. Has the intended purpose of the product changed?
  2. How do you determine that? 
  3. How much has been altered?

This question often arises in regards to daily living aids which are also classified as medical devices. These products are often adjusted to suit a specific patient's or user's needs. Though done with the best intentions, these adjustments may not be considered in the manufacturer's original risk assessment, and may pose an unconsidered risk to the user.  Examples of this are often seen with products like wheelchairs and hospital beds, or by mixing or combining power sources and batteries from different devices.

Documentation and even simple technical risk assessments are always recommended.

Is it safe to repair medical devices with used spare parts from other products?

There is a growing trend of repairing medical devices with used parts from other devices. Though this is often done by technicians who have made a professional assessment and can be an environmentally and economically sustainable practice, there are risks.  

There is no published EU guidance for this practice yet, but there are a couple of important points things to consider:

  • Is the replacement part the same or similar to the original part that it is replacing?
  • Who is implementing and evaluating the repair?
  • Based on which specifications is this repair evaluated?

It is worth your time to write a procedure for the way in which your organisation evaluates, checks and tests whether a part from one device qualifies as acceptable to be used in the repair of another device. For example, write how you visually inspect them for A, B and C and test for X, Y and Z.

It is essential to document the process, even briefly. Consider these questions:

  • How do you determine if a spare part can be used to repair another device?
  • What the intended use of the spare part?
  • Is the part's new intended use the same as the original use? 
  • Will it effect the safety and performance of the repaired product or change its intended use?

If you do not know the original specifications or intended use of the product to be repaired, contact the manufacturer or their authorized representative to determine whether the repair or alteration is too risky.

How can I determine the age and lifetime of our devices?

There are many hospitals and council departments that have reliable (but old) medical devices in storage or still being used in a department. But what should you do if you are unsure about their lifetime and whose responsibility it is if you continue using them?

There are two ways to find out the age and expected lifetime of medical devices:

  1. Check to see if the product's expected lifetime is stated on the labelling and IFU. It can be indicated by a production or manufacturing date. Alternatively, it could be written as a maximum number of daily uses (especially on products with actuators).
  2. Ask the manufacturer.
    For many products that are considered machines under the Machinery Directive, the lifetime of the producct can vary depending depending on frequency of maintenance and use. It is best to ask the manufacturer for their guidelines in writing.

We recommend that you collect and organise the information about the age and expected lifetime of all products in a maintenance system. Written documentation is preferable and should likewise be stored in maintenance sysytem. This will ensure that the knowledge is preserved and that the products are properly maintained .

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