In-house device: An in-house device (IHD) is a device that is manufactured within a health institution established in the European Union that meets all conditions set in Article 5(5) of the IVDR and is used within that same health institution. Laboratory-developed tests are considered and now referred to as ‘in-house devices’ where they meet the definition of an IVD, as defined in Article 2(2) of the IVDR, and meet the conditions of Article 5(5).

Some examples of in-house devices may include:
  • Genetic tests where a primer is purchased and validated internally for clinical use.
  • Use of ‘research use only’ products for clinical application e.g. antibodies for histopathological staining or for use in ‘in-house’ immunoassays or similar.

  • Using a CE marked IVD for a purpose different to that intended by the manufacturer.
  • Using sample types, components or accessories which are not specified by the manufacturer in the instructions for use for the device.
  • Using combinations of IVDs to achieve a certain performance or intended purpose.
  • Use of software which is not CE marked to process data derived from IVDs for a specific medical purpose e.g. Software providing a risk score to determine the likelihood of an individual developing a certain disease based on information derived from IVDs.
We appreciate your feedback on how these changes may affect you and any concerns you may have.

Privacy Notice
By completing this survey you consent to the HPRA processing your personal data. The HPRA will use the responses to this survey will help to inform our approach on providing guidance to stakeholders regarding in house manufacturing. Your personal data will not be shared with anyone and/or transferred outside the EEA by the HPRA. The provision of personal data is not a statutory or contractual requirement, and you are not obliged to provide personal data. No automated decision making, including profiling, will be used.

Question 15 of this survey requests you to consent to the HPRA contacting you in the future, via the email address provided, with guidance and updates related to in house manufacturing and other relevant topics. The data provided in response to this question will be retained until such time as you advise it should be deleted. Any remaining personal data provided will be retained for six months. You may withdraw your consent for the processing of your details at any time without affecting the lawfulness of processing based on consent before its withdrawal. If you wish to withdraw consent or remove your name from the mailing list, please email devices@hpra.ie.

We are using SurveyMonkey for this survey which the HPRA does not control. Data provided when completing the survey may be stored by SurveyMonkey outside the EEA. For more information on how your data will be processed, please read SurveyMonkey’s privacy policy here. The HPRA’s privacy policy is linked here and includes details on how to contact the Data Protection Officer and information relating to data protection rights and how to avail of these rights.

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* 1. Contact Information

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* 2. Do you currently make ’in-house devices’ for use within your health institution?

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* 3. Do you currently modify existing CE marked IVDs for use within your health institution?

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* 4. Do you currently use genetic tests within your health institution?

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* 5. How would you best describe the type of ’in-house devices’ you make/modify and use?

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* 6. What are the main reasons you use ‘in-house devices’?

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* 7. Please estimate approximately how many patient results are reported using ‘in-house devices’ in your establishment per year.

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* 8. Is your Quality Management System (QMS) currently accredited?

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* 9. To what is your QMS accredited to?

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* 10. Which body granted the accreditation?

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* 11. Do you have other forms of certification, licencing, registration etc. related to QMS? If so please specify

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* 12. Do you have a system in place to routinely review non-conformances, deviations, complaints, and to implement corrective actions where necessary?

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* 13. What are the issues you are facing when preparing for the IVDR?

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* 14. Do you have any additional comments in relation to the upcoming changes for in house devices?

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* 15. If you are interested in further information on this topic and consent to the HPRA contacting you in the future, please confirm your email below

0 of 15 answered
 

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