Question 1

What is Article 5(5) of the EU MDR?

Accepted Answer

Article 5(5) of the European Medical Device Regulation (EU MDR) allows eligible health institutions within the European Union to manufacture, modify, and use certain in-house medical devices without CE marking, provided all regulatory conditions are fulfilled. The exemption is intended for devices developed to meet specific patient or institutional needs when no equivalent CE-marked device can achieve the required level of clinical performance.

Question 2

Who can manufacture in-house medical devices under Article 5(5)?

Accepted Answer

Only eligible health institutions established within the European Union, such as hospitals, clinical laboratories, university hospitals, and public health institutes, can use the Article 5(5) exemption. Commercial medical device manufacturers and organizations that are not healthcare institutions cannot rely on this exemption.

Question 3

Do in-house medical devices require CE marking under the EU MDR?

Accepted Answer

No. In-house medical devices manufactured under Article 5(5) are exempt from the standard CE marking procedure because they are not placed on the market. However, health institutions must still comply with applicable General Safety and Performance Requirements (GSPRs), maintain technical documentation, implement an appropriate Quality Management System (QMS), and monitor device performance throughout its lifecycle.

Question 4

What documentation is required for Article 5(5) compliance?

Accepted Answer

Health institutions must maintain comprehensive technical documentation, including the device&#8217;s intended purpose, design, manufacturing process, verification and validation data, risk management records, performance evaluation, and manufacturing controls. They must also prepare a publicly available declaration confirming compliance with the applicable requirements of Article 5(5) of the EU MDR.

Question 5

How can regulatory consultants help health institutions comply with Article 5(5)?

Accepted Answer

Regulatory consultants can assist health institutions by developing compliant Quality Management Systems (QMS), preparing technical documentation, conducting gap assessments, implementing risk management processes, preparing public declarations, and ensuring alignment with EU MDR Article 5(5) and MDCG 2023-1 guidance. Expert regulatory support helps reduce compliance risks while ensuring patient safety and regulatory readiness.

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