Medical Device Regulations are always concerned with patient safety. This includes risk assesments and traceability, among other factors.

The Medical Device Regulation in the EU (2017/745) states that it:

"….aims to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector. At the same time, this Regulation sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other."

This means that each company must ensure that the risks associated with its products are minimized. In addition, the clinical benefits of the products must be demonstrated and documented.

Technical documentation must be contained in the company's Quality Management System (QMS).

There are many requirements to consider, documents to get in order, and decisions to get right when applying for CE approval of medical devices in the EU.

We have created this process chart (PDF), to give you an overview of the many steps and the order in which you should approach them.

Medical devices are classified based on their risk to users. These categories are, from the lowest risk groups to the highest: Class I, Is, Ir, Im, Is, IIa, IIb, and III.

The intended use of your product and it potential risk to users determine into which category it falls. By looking at similar devices on the market and comparing your product to them can give you a good idea of the risk category for your product. Custom-made or altered devices can fall into any risk category.

There are plenty of free webinars and sites where you can learn about Medical Device Regulations on the whole, or dive into specific topics, such as clinical evaluations.

Try Easy Medical Device's free mini course:
https://easymedicaldevice.com/resource/resource-medical-device-regulation/mini-course-mdr/

Or visit their extensive library of podcast interviews with subject matter experts on a wide range of topics:
https://podcast.easymedicaldevice.com/
Or on YouTube:
https://www.youtube.com/c/EasyMedicalDevice

Greenlight Guru also offers many useful resources:
https://www.greenlight.guru/medical-device-resources/ebooks-and-guides

You can find a wide range of well priced digital courses – just search online.

There are some useful webinars created by Quality and Regulatory Professionals. They often help ‘set-the-scene’, teaching you the terms and purpose of  certain tasks.

We recommend that you watch:

Greenlight Guru
https://www.greenlight.guru/medical-device-resources/webinars

EU Guidance documents

There are plenty of guidance documents that can help you understand what is required for medical device regulation.  The EU’s Medical Device Coordination Group (MDCG) and the European Association of Medical Devices Notified Bodies Team (NB) both included endorsed guides and documents on a range of topics:

MDCG
https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en

Team-NB
https://www.team-nb.org/team-nb-documents/

The short answer is "yes". The requirements, prices and timelines can vary for each product risk category in each certifying authority.

But don't be discouraged - we can help you make an overview and gather the required information.

Normally this regulation planning should be a part of your design and development process, but it is often first considered much later in the process.

Have a look at the list of the regulations in the primary markets here:
https://easymedicaldevice.com/resource/resource-medical-device-regulation/

A Quality Assurance Professional or Quality Assurance Manager works within regulated industries, such as medical devices, pharmaceuticals, construction, financial, amongst others.

Their primary goal is to guarantee product or service quality.

In the medical device industry, QA Professionals are often responsible for:

• Ensuring that the company and its current and coming products are in compliance with the relevant standards regulations
• Ensuring that processes are established, followed and updated when necessary
• Preventing product or process flaws by continual improvement of the processes and system
• Establishing platforms to control documentation by appropriate practices, including work flows
• Recording quality issues
• Collecting data and providing trending information
• Assisting with non-conformities and documentation of the investigation, method, results and effectiveness
• Employee training in QA protocol and processes
• Performing internal audits of the company and its suppliers
• Advising against poor or inappropriate decisions

In small companies, it is common that some or all of these tasks are outsourced. 

The main standards that are relevant for most medical device companies are ISO 13485, ISO 14791, ISO 15223-1, and IEC 62366.

For other product specific standards and national or regional specific standards, we recommend you search the internet for information, or contact RAQA for a consultation. With our many years of experience, we can help you determine which standards are relevant for your product in each of your desired markets.

There are many good online QMS systems. Recently, we have worked with:

• ins2outs.com
• D4infonet.dk
• simplerQMS.com
• Open Regulatory

There are also well known ones like:

• Qualio
• Greenlightguru

In addition, some companies use programs such as:

• Podio
• Sharepoint
• Excel/Word

In general, most of these are good systems, though we tend to recommend programs that are designed specifically as Quality Management Systems.  Many software companies choose to build their own system, which can also be a good solution. Regardless of the solution you choose, we can help you optimize your system and populate it with the necessary documents. If you need help figuring out which system to use, let us have a chat about your products and desired markets. We can recommend a QMS that will best fit your needs.

Regardless of what you choose, we highly recommend that you ask for a demonstration of any system you are considering adopting. In addition, ask for additional discounts or features, like one month's free trial.

All processes, from the products conceptualization to its removal from the market, need to be documented and saved in the QMS.

Here are some useful guides focusing on the use of QMS in medical device companies: https://www.greenlight.guru/blog/iso-13485-qms-medical-device

Typically, an employee or external contractor who has taken a course in auditing process and methods can perform internal or suppliers audits. The advantage of having an external contractor conduct audits is that they have no previous contact with the department or supplier and consider things from an objective point-of-view. Additionally, they can shed light on issues with existing processes and conflicting opinions.

Easy Medical Device has a useful blog post about internal audits: https://easymedicaldevice.com/internal-audit/

The short answer is "yes". The requirements vary, especially with regards to reporting and language requirements. They may appear to be similar, but they often have a different approach or different required details.

RAQA can help you identify these differences and implement the necessary adjustments in your practices.

You need a Quality Agreement with suppliers to establish ground rules which reflect the requirements of the industry and business that you are in. The agreement can be simple and focus only on Medical Device Regulation requirements, product specifications and non-conformities, or can be much more detailed.

RAQA recommends that the Quality Agreement is always a separate document than the financial agreement, as they serve different functions.

The purpose of Medical Device regulations is always a question of of patient safety. This includes risk assesments and traceability, among other factors.

The Medical Device Regulations in the EU (2017/745) states that it:

"….aims to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector. At the same time, this Regulation sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other."

This means that the company must ensure that the risks associated with their products are minimized. In addition, the clinical benefits of the products must be demonstrated and documented. Technical documentation must be contained in a Quality Management System (QMS) within the company.

There are plenty of great free webinars and sites where you can learn about Medical Device Regulations as a whole, or dive into specific topics, such as clinical evaluations.

Try Easy Device Devices free mini course:
https://easymedicaldevice.com/resource/resource-medical-device-regulation/mini-course-mdr/

They also have a great library of expert interviews podcasts on a wide range of topics:
https://podcast.easymedicaldevice.com/ Or on YouTube:
https://www.youtube.com/c/EasyMedicalDevice

Greenlight Guru also has plenty of inspiring materials:
https://www.greenlight.guru/medical-device-resources/ebooks-and-guides

There is also a huge range of well priced digital courses – just search online.

There are some useful webinars created by Quality and Regulatory Professionals. They often help ‘set-the-scene’, teaching you the terms and purpose of  certain tasks.

We recommend that you watch:

Greenlight Guru
https://www.greenlight.guru/medical-device-resources/webinars

EU Guidance documents

There are plenty of guidance documents that can show you and help you understand what is required for medical device regulation.  The EU’s Medical Device Coordination Group (MDCG) and the European Association of Medical Devices Notified Bodies Team (NB) both included endorsed guides and documents on a range of topics:

MDCG
https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en

Team-NB
https://www.team-nb.org/team-nb-documents/

The short answer is "yes". The requirements, prices and timelines can vary for each product risk category in each certifying authority.

But don't be discouraged - we can help you make an overview and gather the required information.

Normally this regulation planning should be a part of your design and development process, but it is often first considered much later in the process.

Have a look at the list of the regulations in the primary markets here:
https://easymedicaldevice.com/resource/resource-medical-device-regulation/

This depends on its intended use and how it is categorized.

As an example, there are many welfare apps for rehabilitation and training that qualify as medical devices based on the way they function (data input and output). Some companies have products where just one component, e.g. a software module or physical component, are classified as a medical device, whereas other similar products might fall outside the category.

This is an ever evolving discussion and what seems applicable today may change tomorrow. The current trend it towards increased regulation, so more and more products will be required to meet regualtions in the future.

At RAQA, we recommend instate a scheduled regulatory monitoring process for your given product categories in all of your chosen markets.

Medical devices are classified based on their risk to users. These categories are, from the lowest risk groups to the highest: Class I, Is, Ir, Im, Is, IIa, IIb, and III.

The intended use of your product and it potential risk to users determine into which category it falls. By looking at similar devices on the market and comparing your product to them can give you a good idea of the risk category for your product. Custom-made or altered devices can fall into any risk category.

 Health and welfare technologies can be classified under many different types of regulations, and many more are on the way. In addition to classifications, there are the relevant standards. Each classification and regulation require different types and levels of documentation. That is why it is essential to scope which regulations and legislation are relevant for your intended markets early in the development process, as the approval processes have different timelines and costs different amounts in each market.

Depending on which market(s) you are considering for your products, authorities often evaluate health and welfare products differently, depending on their intended purpose, where they are intended to be used (setting), and their intended effect. 

This does not usually pose a problem and the required approvals are often swift, which is good for you and your users. However, check whether the updates are categorized as major or minor, as this could potentially warrant a new UDI or classification.

Under the MDR, the definition of major or minor changes are described in the following guidances:

• MDCG 2020-3: Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
• MDCG 2018-1 Rev.4 Guidance on BASIC UDI-DI and changes to UDI-DI
• MDCG 2018-5 UDI Assignment to Medical Device Software

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:

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.

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

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.

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.

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 .