Custom-Made Device (CMD) – Webinar Recordings

On 26 October 2023, the HPRA held an information session on Custom-Made Devices (CMD). The webinar aimed to provide an overview of the Medical Devices Regulation (MDR) and how it applies to custom-made devices. It provided practical information regarding the application of the MDR for custom made device manufacturers and gave insights into key areas such as classification, conformity assessment, vigilance reporting and technical documentation requirements.

Recordings of the webinars are available to view below.

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Placing Custom-Made Devices on the market

In the first session James McCarthy provides an introduction to the Medical Device Regulations (MDR), qualification and classification of custom-made devices and a brief overview of conformity assessment.

Custom-Made Device manufacturer requirements under MDR

In the second session Niamh Herlihy presents some of the key manufacturer requirements within Annex I MDR – the General Safety and Performance Requirements.

Custom-Made Devices – demonstrating regulatory compliance

In the third session Dr. Jennifer Roche provides an overview of inspections for Custom-Made device manufactures, what are the relevant requirements for products, documents and records and how do manufacturers demonstrate compliance.

Complaints and reporting to the competent authority – Post-market surveillance and vigilance

In the fourth session Ivana Hayes presents the requirements for handling complaints relating to Custom-Made devices and reporting these to the regulatory authorities.

Questions and answers session

The presentations were followed by a questions and answers session which addressed a number of topics.