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EU MDR 2017/745 Custom-made devices Blog Post

If you are working on medical devices, the majority of you may have heard about a category of products but never really worked on it and it is Custom-made medical devices.

This category of product exists also on the MDD 93/42/EC and is still available on the new MDR 2017/745. On the In-vitro diagnostic regulation IVDR 2017/746, this is not present.

  • But what is considered a custom-made medical device ?
  • What are the rules to put this product on the market ?

I will try to provide you as much information as possible for that. So stay focused.

Table of Contents

Custom-made Medical device definition

Let’s first define what is a custom-made device. Below is the MDR 2017/745 definition Article 2(3) and we can start from there. I will then provide you an explanation as there are some important elements to understand.

custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional qualifications which gives, under that person’s responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.

However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices;

 

Clarification

First, a thing you have to understand is the fact that a custom-made device is not a standard product, but it is a product requested by an authorized professional under a written prescription.

For example, a Medical Doctor that wants a specific device that doesn’t exist on the market for his patient.

This Medical Doctor will provide his own requirements like a specific design that will match the anatomy of the patient in the case of an orthopedic product.

If you want me to provide you an example, let’s talk about a bone replacement. If you had a tumor on a certain part of your skull and that the removal of this tumor leaves a big hole then a Medical Doctor can ask for a specific implant with the exact dimensions needed to fill the hole. This is not something that is ready to use on the market so then it’s a custom-made device.

Mass-Production

But you can also see that there is a second part of the definition where we talk about Mass-Production. Some manufacturers may be selling some implants that are parts of their portfolio. Let’s take the example of a set of screws.

If a Medical Doctor asks you under a written prescription to increase of 1 cm the length of the screw that goes on the femoral bone because the higher size on the portfolio is not enough, then it is not a custom-made device. Originally this product is mass-produced by the manufacturer for all his customers and the small change that is provided is not really changing the anatomy of that device.

It is needed to match a certain patient but this cannot be considered as custom-made.

If you have a shoulder implant on your portfolio and the prescription of the doctor asks you to change a small design to fit specific anatomy, this is not a custom-made device.

Is 3D printed device considered as custom-made?

For that you will need to read my article specifically dedicated on 3D-printed products.

The quick answer is, no this is not considered as a Custom-made device. But there are some reason for that. 

Requirements to register a custom-made device

When you can confirm that your product is really a custom-made device, then we can move forward. There are 2 categories of Custom-made devices:

  • General Custom-made devices
  • Class III implantable Custom-made devices

For general devices, you will need to follow the requirements on Annex XIII.

  • Draw up a statement (See proposed draft)
  • Keep all the documents showing conformity available to Competent Authority
  • Archive for 10 years and 15 years for implantable devices
  • Follow the performance of the devices through PMCF

I will try to provide you more information on each of those requirements.

MDCG 2021-3

The MDCG group issue a guidance in the format of Question and Answers for Custom Made Devices.. 

What is interesting in this guidance is the integration of some vocabulary like:

  • Adaptable medical devices
  • Patient match devices

Within the definition of which devices are not considered as CMD we have:

  • Devices that are mass-produced which need to be adapted to meet the specific requirements of any professional user. This is what we call adaptable devices
  • Devices that are mass-produced by means of industrial manufacturing processes, potentially made in accordance with the written prescription of an authorised person. We can integrate that on the patient match devices.
So be careful that your product are not falling under these categories otherwise you are not considered as custom-made device.

Examples

Below are some examples of Adaptable devices and Patient Match devices. You can find more information on the MDCG 2021-3 guidance

Adaptable Devices

Patient Match Devices

  • Certain spectacle frames and optical glasses (assembled together to form spectacles).
  • patient fitted wheelchairs.
  • hearing aids (otoplastic and amplifier).
  • orthotic braces.
  • exo-prosthetics.
  • Plates used to fix a broken bone, which are made by 3D printing, based on a template model and DICOM files/ images of the patient. The plates are printed within the validated dimensional ranges allowed by the specified design envelope under the sole responsibility of the manufacturer.
  • Cutting guides used in procedures such as knee arthroplasties, or guides used for pedicle screw placement, that are made by 3D printing based on MR or CT data to match a specific patient.
  • Mandibular implants produced by a 3D printing manufacturer, from a template model and DICOM files.
  • Made to order contact lenses which are produced on request typically in batches with validated or verified production processes using standardised tools and materials and within clearly specified dimensions. No specific or individual design process necessary.
  • An externally worn orthosis to support, prevent or assist body functions, based on external 3D scan images and or measures, by a manufacturer who produces this under his sole responsibility, within validated parameters.

PODCAST EPISODE

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

In the case your product is implantable and class III then it’s another story. This is a more risky product so you’ll have some additional requirements to follow.

First, you’ll have to do the same as general custom-made device and drawing a statement with the same information. And then you have 2 options:

  • Annex IX – Chapter I
  • Annex XI – Part A

So let’s see the difference between both.

Listen to the Medical Device made Easy Podcast

Documentation requirements

The important document for custom-made products is the statement that you need to draw up. There are no specific form existing but just some requirements on what should be inside. So to help you I create my example which is only a draft that you can rework.

Statement

The requirements on this statement are the following:

  • the name and address of the manufacturer, and of all manufacturing sites,
  • if applicable, the name and address of the authorized representative,
  • data allowing identification of the device in question,
  • a statement that the device is intended for exclusive use by a particular patient or user, identified by name, an acronym or a numerical code,
  • the name of the person who made out the prescription and who is authorized by national law by virtue of their professional qualifications to do so, and, where applicable, the name of the health institution concerned,
  • the specific characteristics of the product as indicated by the prescription,
  • a statement that the device in question conforms to the general safety and performance requirements set out in Annex I and, where applicable, indicating which general safety and performance requirements have not been fully met, together with the grounds,
  • where applicable, an indication that the device contains or incorporates a medicinal substance, including a human blood or plasma derivative, or tissues or cells of human origin, or of animal origin as referred to in Regulation (EU) No 722/2012.

I created a template. Check here.

GSPR

Within the MDD 93/42/EC, custom-made devices should comply with Annex I – Essential Requirements. On the MDR 201/745, this is the same but now it’s called General Safety and Performance Requirements or GSPR. This is still in Annex I.

To be able to provide your custom-made device to the patient, you’ll need to check that you are complying with these requirements and keep a copy of it. On the statement, you will have to write a sentence to confirm it.

PRRC - Person Responsible for Regulatory Compliance

I have created a blog post and a video on this topic. The PRRC is the Person Responsible for Regulatory Compliance.

The MDR requires that you have in your organization a PRRC and for custom-made products this PRRC should be knowledgeable on the specific custom-made products you are providing. In case you can also use an external consulting company but there are also some critical requirements.

I really encourage you to review this blog post.

Archiving of documents

The requirements for medical devices is to archive the documentation for a minimum of 10 years and if your products are implantable, this should be a minimum of 15 years.

The archiving part is really important. This is critical that you can provide a copy of the documents used to put the custom-made on the market to competent authorities when required.

So having a record retention procedure is key. You need to define your system for how long these documents should be kept and confirm that the conditions of retention are adequate.

Don’t underestimate this requirement. Because if 10 years from the day you provided your product, if the competent authority is contacting you, you should be able to pull out the document quickly. So anticipate now than suffering later.

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Post-production information - PMCF

The manufacturer of custom-made device should still continue to gain experience from the post-production phase. 

PMCF or Post-market Clinical Follow-up is one mean that can be used for that as described in Annex XIV Part B.

The manufacturer is still obliged to report any issues identified to the authorities as described in article 87(1) of the MDR 2017/745.

So, you should not consider that a custom-made device is not following some requirements made to generic devices. 

Quality Management System

On the requirements for custom-made, it is not specifically said that you need a certified Quality System if you are only working on custom-made devices unless this is a class III implantable.

For class III implantable you should follow a path where a certified QMS is needed

For the other devices, I really encourage you to use one as some of the requirements will be followed in a better way.

For example (this list is not exhaustive):

  • Form to use for the statement
  • Procedure to explain how to fill the form
  • Archive rules for documents
  • Inclusion of the Custom-made device review on the Post-marketing procedure

For sure if you are a small company, you can say that anyway there are not a lot of people that are doing that, but if these persons are leaving your company you lose a lot of know-how. 

Better to write that in a procedure to be sure that you are compliant with the requirements and to be sure that everybody is doing the same thing.

GAP ASSESSMENT TOOL

You need a ready to use tool to make a Gap Assessment of the MDR, MDSAP, ISO 13485. Click on the link below to see the offer

Decision tree

To help you summaries what we just discussed, I create an infographic with a decision tree. This will tell you what you should do for each category.

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

The short answer is NO.

The long answer you can find it on “Article 20 – CE marking of conformity” of the Medical Device Regulation MDR 2017/745.

It says:

Devices, other than custom-made or investigational devices, considered to be in conformity with the requirements of this Regulation shall bear the CE marking of conformity, as presented in Annex V.

So if your product is a custom-made or investigational device you have no requirements to place the CE mark logo.

Custom-made device (MHRA)

European Authorized Representative United Kingdom

The UK MHRA issued a guidance regarding the registration of Medical Devices in the UK, You can find inside the definition of a Custom-made for the UK market.

You have to be careful, the UK MHRA is for the moment following the MDD 93/42/EC for the UKCA but as they are in transition to issue a new legislation, the information provided on this guidance may change.

Don’t hesitate to check this link.

In the case you are located outside of the UK and you need to register a Custom-made device in the UK, you should then have a UK Responsible person (Same as Authorized Representative in EU) to do that for you.

Contact us if you need a UK Responsible Person. Our office in the UK can be your representative and will help you for all the necessary actions to register your devices in the UK.

Example of Custom-made device statements

I wanted to provide you an example of the custom-made device statement. But I will also give you the link to the MHRA website where some specimens are also available.

There are no official forms so this can depend on your product. The template I will provide you is only for information and should be adapted to your situation. So don’t take it as an official document.

It will include the requirements I mentioned on previous chapter but you will need to evaluate it on a case by case.

Form Medical Device Custom Made Statement EU MDR 2017/745

Competent authorities registration

Easy Medical Device is providing Regulatory changes from all over the world

On this part of the article, I will try to provide you links of other countries laws or links to manage Custom-made devices. Like for example, Custom-made Medical Device in Australia with the TGA or in UK with the MHRA…

Switzerland

Australia (TGA)

UK (MHRA)

The United States (FDA)

Other places where we can register Custom-made Devices?

Leave a comment with the country and the link

Thank you very much

This website can only work with your participation so I really thank you for your support

More questions?

I am waiting for your questions on the comment section. I will be really happy to help you to answer them.

Don’t forget to even comment if you like this content. This will also motivate me to continue.

Thanks to all for your support.

Summary
How to place a Custom-made Medical Device on the market?
Article Name
How to place a Custom-made Medical Device on the market?
Description
There are many categories of Medical Devices but this one is really special. You can market it very quickly without to wait for a lot of studies and more importantly, it's a unique product only made for 1 person and this is the Custom-Made Medical Device.
Author
Publisher Name
Easy Medical Device
Publisher Logo
Categories: Europe

Monir El Azzouzi

Medical Device expert. Monir founded Easy Medical Device to help Medical Device companies to place compliant products on the market. He proposes his consulting services so don't hesitate to contact him at info@easymedicaldevice.com or +41799036836 My objective is to share my knowledge and experience with the community of people working in the Medical Device field.

UK Representative from January 1st, 2021

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