Medical Device Regulation and CE Marking

Why is this action required?

This action is required to reinforce the existing processes and regulations in place at both EU and national level. This will further strengthen awareness for the safe use of medical devices within the HSE/HSE funded services. The actions undertaken will help give assurance to the HSE and to those that use our services that medical devices in use within the HSE and its funded services are operating under the appropriate regulations.

A CE mark on a medical device indicates that it conforms to EU medical device regulation. While CE marks may be found on other products (e.g. electrical goods, toys), the CE mark on a medical device indicates that it meets the specific requirements of the medical device regulation (MDR). A medical device CE mark has a four-digit number*** below it to indicate the specific notified body that assessed and certified it. Further information is available in the Medical Device Regulation HSENPSA 002/2023 Supplementary Information.

***A notified body four-digit identification number will not be present on some medical devices such as low-risk (certain Class 1) devices.

What else do I need to do?

If new techniques and/or technologies are being considered, healthcare staff must adhere to their local governance requirements in this regard. Guidance should also be sought from the respective professional bodies. If a HPRA authorised, but non-CE marked medical device is being considered for use (for clinical research or compassionate use), it is essential that informed consent for its use is obtained from the patient/service user involved. All incidents/near misses related to the use of a medical device must be managed as per the HSE’s Incident Management Framework and reported onto NIMS and to the manufacturer of the medical device. The HPRA also operates a vigilance reporting system to receive reports of adverse incidents or near misses. Reports can be submitted to the HPRA using the online form. As per the HSE’s Open Disclosure Policy any medical device related incident or near miss should also be disclosed to the patient/service user involved, in particular where there was harm.

What stakeholders were involved in issuing this HSE National Patient Safety Alert?

This alert has been developed collaboratively by the:

• HSE National Quality and Patient Safety Directorate, Office of the Chief Clinical Officer
• Health Products Regulatory Authority
• HSE Acute Operations
• HSE Procurement
• HSE Capital and Estates, National Medical Devices Office
• HSE Clinical Programme in Surgery
• HSE National Patient Safety Alerts Committee

What evidence supports the issuing of this HSE NPSA?

• Medical Device Regulation (EU) 2017/745
• HSE Medical Device Regulatory Information
• HSE Medical Device Equipment Management Policy
• HSE Medical Device Equipment Management Best Practice, Guidance for Service Areas

Appendix

In the context of this alert a risk assessment will take a measured approach to identifying any issues or practices that may indicate non-compliance with the MDR and CE marking requirements in effect in Ireland since May 26th 2021*, which could lead to harm. It will consider key priorities/proportionate response to risks.

Instead of specifying the exact detail of the assessment requirements in this alert, an organisation should determine what meaningful assurances are required, in particular in relation to the points listed in the actions section of this alert. This will require each organisation to identify and to implement required measures using an investigative approach to confidently determine compliance/assurance.

This requires:

- Review of local governance process (policy, risk management processes, Medical Devices Committee, etc.)

- Staff knowledge assessment/training needs assessment relating to the regulatory requirements relevant to their role

- Review of tender/procurement process

- Audit/spot-check audit of medical devices regarding the CE marking requirement

- Focus on high-risk areas/medical devices/services

- Audit of the reporting rates and management of medical device incidents and near misses

- Services to consider developing or adopting new safety initiatives e.g. safety prompts to help prevent harmful incidents

- Other necessary measures as determined by the organisation

Any risk assessment should be documented and feed into the organisation’s compliance, vigilance and quality and safety agenda. Identified issues or risks must be mitigated against and improvement actions implemented.

Further guidance on how to undertake a risk assessment is available in the HSE Risk Management Policy

*Prior to May 2021, medical devices were regulated under the Medical Devices Directive 93/42/EEC and the Active Implantable Medical Devices Directive 90/385/EEC and specific provisions relating to devices/procedures under this regulatory framework are outside of the scope of this supplementary information. In Vitro Diagnostics are also outside scope as they are regulated under Regulation (EU) 2017/746

**Some specific categories of medical devices are not required to bear a CE mark; however, they are required to meet regulatory requirements as set out in the MDR. Such circumstances relate in particular to custom-made medical devices and in-house manufactured medical devices as well as those exemptions where an application to the HPRA needs to be made (for clinical research and for compassionate use). For further detail see Medical Device Regulation HSENPSA 002/2023 Supplementary Information.

***A notified body four-digit identification number will not be present on some medical devices such as low-risk (certain Class 1) devices.

Where can I get further information?

• For any queries on the HPRA please see hpra.ie or contact devices@hpra.ie
• For queries on this or any HSE NPSAs in general please email patientsafetytogether@hse.ie

HSE National Patient Safety Alerts (NPSA) are high-priority communications about patient safety issues, which require HSE services and HSE funded agencies to take specific action within an identified timeframe. They are developed with relevant people including subject matter experts and patient representatives.