Marketing custom-made medical equipment can be a challenging procedure that involves several regulatory regulations and high criteria for quality assurance. The main procedures for releasing a specially created medical device onto the market will be covered in this blog, including design and development, testing and validation, regulatory compliance, and marketing and distribution plans. By being aware of these processes, you can make sure that your specially produced medical gadget satisfies all standards and reaches its target market in a secure and efficient manner.

Custom-made Medical device definition:

A custom-made medical device, also known as a custom device or a made-to-order device, is a medical item created and produced specifically for a single patient. Auricular splints, dentures, orthodontic tools, orthotics, and prosthetics are a few examples of custom-made medical equipment. An individual patient’s unique medical needs, which are incompatible with typical off-the-shelf medical devices, are to be met by a custom-made medical device.

Custom-made medical devices can enhance a patient’s mobility or functionality, help treat medical conditions or injuries for which there may be no other effective treatments, and improve the patient’s quality of life by designing and manufacturing a device that is specifically suited to their individual anatomical or physiological characteristics. To improve the patient’s results, customised medical gadgets can also be applied during operations or as a component of continuous care.

Clarification:

A custom-made device is not a normal product; rather, it is a product required by a licensed expert under a written prescription, which is the first thing you need to grasp. You need to clarify the needs and requirements based on which the actual device will be made!

Mass-Production:

Medical gadgets that are mass-produced are those that are created in big quantities and are designed to be used by numerous patients. Without being customised for specific patients, these devices are made to a standard specification and are intended to fulfil broad medical demands.

Is a 3D printed device considered custom-made?

If a 3D printed equipment is created specifically for a patient based on their particular anatomical or physiological traits, then yes, it may be said to be custom-made. Medical 3D printing involves creating physical reproductions of anatomical structures in order to create medical equipment directly or indirectly. Using MRI, X-Ray CT, and other 3D imaging techniques, you can create digital models of structures for 3D printing. Recently, this approach has become more widely used for clinical and research-based healthcare activities. With 3D printing, it is possible to produce small batch sizes quickly and affordably, which is a significant benefit.

Over the following few years, it is projected that as the cost and accessibility of the technology decline, so will its application in medicine. It is anticipated that this development will lead to increased 3D printing use in clinical and educational settings, better regulatory guidance, and more competition among manufacturers of medical devices.

Requirements to register a custom-made device:

We can continue when you can attest that your product is indeed a custom-made device. There are two types of specialised equipment:

• General Custom-made devices
• Class III implantable Custom-made devices
• You must adhere to Annex XIII’s standards for generic devices.
• Make a statement
• Maintain all conformity-demonstrating documentation in the Competent Authority Archive for 10 years and 15 years for implanted devices.
• Utilise PMCF to monitor the devices’ performance.

MDCG 2021-3:

The MDCG group published a guide for custom-made devices in the form of questions and answers. What makes this blog intriguing is the amount of vocabulary it provides, such as:

• Adaptable medical equipment
• Patient match devices

We have the following devices within the definition of what constitutes a CMD:

• Mass-produced items that need to be modified to satisfy the unique needs of any professional user. We refer to these as adaptable gadgets.
• Devices that are mass-produced using industrial manufacturing techniques, maybe following a written prescription from a qualified individual. The patient match devices can incorporate that.

Therefore, take care to ensure that your product does not fall into one of these categories otherwise it will not be regarded as a custom-made item.

Podcast:

You can explore the world of custom-made medical devices, from design and development to regulatory compliance and patient impact, in several podcast episode available online.

The distinction between general custom-made and class III implantable device:

A podcast called Medical Device Made Easy provides information, advice, and tactics for creating and marketing medical devices. It is hosted by experts and includes conversations with business leaders who discuss various facets of the creation of medical devices.

Documentation requirements:

The statement that you must create is a crucial document for things that are produced to order. There isn’t a specific form in existence; only a list of what must be included. The following conditions must be met by this assertion:

• The manufacturer’s name, address, and locations of all manufacturing facilities,
• The name and address of the authorised representative, if relevant,
• Information allowing the device in question to be identified,
• A declaration that the equipment is only meant to be used by a specific patient or user, identified by name, abbreviation, or numerical code,
• The name of the person who wrote the prescription and is permitted to do so under national law due to their professional credentials, as well as, if appropriate, the name of the healthcare facility,
• The product’s precise attributes as specified by the prescription,
• A declaration that the device in question complies with the general safety and performance standards listed in Annex I and, if appropriate, a list of the requirements that haven’t been fully satisfied, along with an explanation of why,
• If appropriate, a statement stating the device includes or incorporates a medical ingredient, such as a derivative of human blood or plasma, human or animal tissues, or cells, as defined by Regulation (EU) No 722/2012.

PRRC – Person Responsible for Regulatory Compliance:

The PRRC is in charge of ensuring regulatory compliance. According to the MDR, your company must have a PRRC, and if you are selling customised goods, this PRRC needs to be informed about those particular goods. If necessary, you can also hire an outside consulting firm, but there are several important prerequisites.

Archiving of documents:

If your items are implantable, the documentation must be kept on file for at least 15 years and at least 10 years for medical devices. The archiving component is crucial. It is essential that you can give a copy of the paperwork used to promote the custom items to the appropriate authorities upon request.

So, it’s important to have a record retention policy. You must specify in your system how long these documents should be retained and ensure that the retention requirements are suitable. Don’t undervalue the need for this. Because you should be able to promptly access the document if the competent authority contacts you 10 years from the date you gave your product.

Post-production information – PMCF:

The manufacturer of a special equipment should keep learning from the post-production stage. According to Annex XIV Part B, one method that can be utilised for this is PMCF, or Post-market Clinical Follow-up. In accordance with article 87(1) of the MDR 2017/745, the manufacturer is still required to notify the authorities of any difficulties that are discovered. As a result, you shouldn’t assume that a custom-made gadget does not adhere to requirements established for generic devices.

Quality Management System:

If you are simply working on custom-made devices, unless they are class III implantables, it is not clearly stated that you need a certified Quality System. You should choose a route for class III implantables when a certified QMS is required. We strongly advise using one of the other devices so that some of the requirements can be met more effectively.

For instance (and this is not an entire list):

• Suitable format for the assertion
• How-to guide for filling out the form
• Guidelines for document archiving
• Review of custom devices included in the post-marketing process

If your business is small, you can undoubtedly argue that there aren’t many people doing that, but if these employees leave, you lose a lot of expertise. It is preferable to include that in a procedure to ensure that you are following the rules and that everyone is acting in the same way.

Decision tree:

● Identify the need

● Assess feasibility

● Evaluate risks

● Evaluate benefits

● Consider regulatory requirements

● Determine design specifications

● Develop and test prototype

● Manufacturing and quality control

● Post-market surveillance

● Re-evaluate

Should I put the CE logo on a Custom-made device?

The quick response is “no”. The detailed response is available under “Article 20 – CE marking of conformity” of Medical Device Regulation MDR 2017/745. Devices that are thought to meet the standards of this Regulation, excluding custom-made or experimental devices, must display the CE mark of conformity described in Annex V. Therefore, you are not required to include the CE mark logo if your product is a custom-made or experimental device.

Custom-made device (MHRA):

The definition of a Custom-made for the UK market is contained in the UK MHRA’s advice on the registration of medical devices in the UK. You must exercise caution because the UK MHRA is currently adhering to MDD 93/42/EC for the UKCA, but because they are working to issue new laws, the information on this advisory is subject to change. If you live outside of the UK and need to register a custom device there, you should ask a UK Responsible person (also known as an Authorised Representative in the EU) to handle it on your behalf.

Competent authorities’ registration:

• Prosthetic limbs that are constructed specifically for each patient’s anatomy and functional requirements can be created.
• Dental implants made to order can be constructed to suit a patient’s mouth perfectly and offer the best possible function and appearance.
• Hearing aids that are manufactured to order can be tailored to a patient’s exact hearing requirements and preferences.
• Patients with illnesses like cerebral palsy or multiple sclerosis can benefit from the support and improved movement that can be provided by specially tailored orthotics.
• To simplify complicated surgical procedures and enhance patient outcomes, custom surgical equipment might be produced.
• Devices for assistive technology that are built specifically for a person with a disability can help them carry out daily tasks and enhance their quality of life.
• To replace or repair damaged bone or tissue in the body, such as in cases of spinal cord injury or joint replacement, custom implants can be manufactured.
• In order to provide more precise and individualised assessments of a patient’s medical status, customised diagnostic instruments might be created.

FAQ’s: