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In our previous blogs, we have discussed about the following topics.

EU MDR 2017/745 is live now. And it is the most trending topic in Medical Device Regulatory Affairs field. Most of the medical device companies are in EU MDR Transition to make sure that they can sell their products in Europe.

Therefore, it is important for Medical Device QA/RA Professionals to know in detail about EU MDR 2017/745. In today's blog, we are going to discuss about the requirements of Custom-Made Devices as per EU MDR 2017/745.

Let's get into the topic.

Procedures for Custom-Made Devices

In EU MDR 2017/745, Annex XIII provides the requirements for Custom-Made Devices. Let's discuss about the requirements.

For Custom made devices, the statement containing the following information shall be provided by the manufacturer or authorized representative of the custom-made medical device:

The name and address of the manufacturer and all of their manufacturing sites. If applicable, name and address of the authorized representative shall also be provided.

The name of the person who made the prescription for the custom-made device and who is authorized by the national law based on their professional qualifications to make such prescription. The name of the concerned health institution shall also be provided.

As indicated by the prescription, information about any specific characteristics of the custom-made device shall be provided.

Information that the custom-made device will be exclusively used by a particular patient or a user shall be provided as a statement. The statement shall also identify the name, an acronym or a numerical code.

A statement that the custom-made device in question conforms to Annex I, General Safety and Performance Requirements of EU MDR 2017/745 shall be provided. If applicable, information about any general safety and performance requirements which have not been fully met shall be provided.

If applicable, information that the custom-made 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 shall be provided.

Any data allowing the identification of the custom-made device in question.

The manufacturer of the custom-made device shall keep available the documentation containing information about their manufacturing sites for the competent authorities. The documentation shall also allow an understanding to be formed regarding the design, manufacture and performance of the custom-made device, including its expected performance, so as to allow the assessment of conformity by the competent authorities with respect to the requirements of EU MDR 2017/745.

The manufacturer of the custom-made device shall take all necessary actions to ensure that their manufacturing process produces devices that are manufactured in accordance with the documentation submitted to the competent authorities.

The statement provided by the manufacturer of the custom-made device as mentioned above shall be kept for a period of atleast 10 years at the disposal of competent authorities after the custom-made device has been placed on the market.

If the custom-made device is an implantable device, the statement provided by the manufacturer shall be kept for a period of atleast 15 years at the disposal of competent authorities after the custom-made device has been placed on the market.

The experience gained during the post-production phase of the custom-made device shall be reviewed and documented by the manufacturer, including from Post Market Clinical Follow-up as referred in Part B of Annex XIV. The manufacturer of the custom-made device shall also implement appropriate means to apply any corrective action.

The manufacturer of the custom-made device shall report to the competent authorities about any serious incident or field safety corrective actions or both as soon as the manufacturer learns about them. The reporting to the competent authority shall be in accordance with Article 87(1), Reporting of serious incidents and field safety corrective actions.

Now I hope you have acquired some basic knowledge about the requirements of custom-made devices as per EU MDR 2017/745. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.

NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.

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