Key regulatory considerations for health institutions in Ireland using medical devices and IVDs

When sourcing medical devices, physical and document checks should be conducted to ensure the devices are CE marked for their intended medical purpose.  Compliance verification checks will help to ensure devices are CE marked, compliant, safe and perform as intended. 

In this section, we provide information on checking compliance of a device. 

CE marking

In most cases, medical devices and IVDs must be CE marked before they can be placed on the EU market and used in healthcare settings or in health services.

A CE mark indicates that a device has been assessed for its intended purpose and deemed to meet EU safety and performance requirements. There are various ways that a manufacturer can get a CE mark for a device.

For most devices, the manufacturer applies the CE mark when their device is assessed and certified by a notified body. A notified body is an independent certification body that has been designated as competent to assess and certify devices based on their specific expertise. 

Upon successful completion of assessment of the manufacturing site and the manufacturer’s technical and clinical documentation for the device, the notified body issues a CE certificate. This certificate allows the manufacturer to apply the CE mark to the device and place it freely on the EU market, without the need for national authorisation or checks. 

Where a device has successfully completed a notified body assessment, a 4-digit number will also accompany the CE mark. This unique number identifies the relevant notified body that carried out the assessment and issued the CE certificate. 

For the lowest risk devices (i.e. class I, class A), the manufacturer self declares compliance with the regulatory requirements and draws up a Declaration of Conformity having completed a conformity assessment themselves. 

The physical presence of a CE mark on a device should be checked at goods in/receipt. This check should be part of an established process and ideally as part of a quality management system in place in the health institution. 

Certain devices do not require a CE mark. However, there are criteria and processes to be followed for these limited exceptional cases (e.g. compassionate use cases and clinical investigations).   

Declaration of conformity

Manufacturers must draw up and sign an EU declaration of conformity (DoC) document to declare their devices comply with applicable regulatory requirements. A DoC must be drawn up and signed before the manufacturer assigns the CE mark to the device.  

When sourcing a device, it is important to request an electronic copy of the DoC. 

It is also important to enquire about the availability of a DoC when sourcing medical devices. A DoC has useful information such as:

• Confirmation of the regulatory framework under which the product is regulated (e.g. MDR, IVDR)
• Device Name 
• Single Registration Number (SRN) - which indicates the manufacturer is registered on the European database, EUDAMED
• The Basic UDI-DI (unique device identifier) for the device  
• Device Risk class 
• Notified body name and number (if applicable)

Manufacturer self-declaration document

Manufacturer self-declaration documents are only relevant to devices which were certified in accordance with the previous set of Directives , (i.e. the MDD, AIMDD or IVDD). They are not relevant to new devices certified under Regulation (EU) 2017/745 on medical devices (MDR) or Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). 

For manufacturers of Directive certified devices to continue to place their devices on the market, they must meet certain criteria that are linked to specific deadlines. 

A manufacturer self-declaration document acts as a statement of compliance to these requirements and can be requested from the manufacturer supplying these devices to verify they meet the requirements.

For more information about these requirements and deadlines for medical devices, please review our MDR transitional provisions webpage. 

For more information about these requirements and deadlines for IVDs, please review our IVDR transitional provisions webpage. 

Article 10a MDR requires manufacturers and distributors to inform health institutions of anticipated supply  interruption or discontinuation of device supply to the EU market.  This applies to certain devices that could result in serious harm or a risk of serious harm to patients or public health. Supply disruption notifications increase visibility on device availability issues for the health service. 

Health service personnel involved in the procurement, management and use of devices and IVDs in Irish hospitals need to be aware of notifications of interruptions or discontinuations of device supply and help prepare for alternative devices or treatment options. 

Upon receipt of a device supply disruption notification, relevant health personnel should take steps to manage notifications. This provides health institutions with time to take  actions and ensure continuity of patient care.

For more information about the supply disruption requirements, and the steps to be taken following receipt of notifications, please visit our Medical device and IVD disruptions webpage.

The MDR and IVDR introduce a Unique Device Identification (UDI) system to enhance device traceability. A UDI contains two components, a device identifier (UDI-DI) and a production identifier (UDI-PI). This information can be found on the device label or its packaging in the form of a barcode or other means. 

Hospitals are required to keep, preferably by electronic means, the UDI information of Class III implantable devices they have been supplied. 

We encourage hospitals to capture and storage the UDI information of all classes of devices and IVDs they have been supplied. 

Hospitals should ensure they have a system in place to track and trace all devices in use in the hospital. This may be important in situations such as product recalls to identify patients who have received specific devices. 

Implant card information 

In certain scenarios, health institutions must supply an implant card to a patient. 

Implant cards allow patients to identify themselves as a person requiring special care in relevant situations. They also inform emergency staff about care needs for patients. 

It is important for health institutions to ensure relevant devices are accompanied by implant cards. 

This can be done by conducting physical checks at good in/receipt using a rationalised sampling method. 

Implant cards should be designed to have empty fields relating to the:

• Name of the patient or ID.
• Name/address of HI or HCP who performed implantation.
• Date of implantation.

These fields should be filled out by the implanting healthcare institution or healthcare provider.