HPRA Notice to Importers Based in Ireland
Updated: 31 May 2021
Notice to Stakeholders
To assist stakeholders in complying with their responsibilities and obligations under the Medical Devices Regulation (MDR), the HPRA is outlining our current national position in relation to a number of importer FAQs. It is important to note that an importer/distributor FAQ document is currently under development at an EU level and is expected to be published in the coming months. Once this document is published, the HPRA will align with the EU position.
1) What is meant by 'accompanying documentation' under Article 13(3) MDR?
In accordance with Article 13(3) of the MDR, importers are required to indicate their details on the device, or on its packaging, or in documentation accompanying the device. Accompanying documentation may be separate from or affixed to the devices, as long as it allows the importer to be located and permits healthcare professionals, patients or users to report suspected incidents to them (Art. 13(8)). This may be achieved by, for example, affixing a sticker to the label or the IFU (as long as the sticker accompanies the device throughout the supply chain).
Any additional label should not obscure any information on the label provided by the manufacturer (in accordance with Annex I 23.2).
It is also noted that the distributor should refrain from selling products where documentation or importation information is missing (Article 14(2)(c).
2) Must importers and distributors complete checks if the device is still certified under MDD as a 'legacy device'?
Economic operators’ responsibilities and obligations apply from the date of application of the MDR. This includes the importer and distributor responsibilities set out in MDR Articles 13 & 14, which apply to both MDD legacy devices and MDR-compliant devices. In accordance with Article 120(3) of the MDR, legacy devices can continue to be placed on the market after 26 May 2021 if they continue to comply with the Directives, including the Directive labelling requirements. Therefore, the importer’s details do not need to be included on the label of MDD legacy devices.
3) Can an authorised representative or manufacturer perform verification checks on behalf of importers or distributors?
No. All economic operators must fulfil their obligations in accordance with the Regulations. It is not possible to delegate these legal responsibilities to upstream economic operators. It is understood that some activities may be sub-contracted out to other organisations, however this does not absolve an importer or distributor from their legal obligations or liability. Furthermore, it is not possible for one importer to delegate their legal responsibilities to another importer, as no such provision is stipulated in the definition of an importer or in Article 13. The rationale behind this is to facilitate oversight of the supply chain and to help ensure traceability. Article 25 relating to traceability within the supply chain would need to be complied with.
4) Can importer/distributor verification checks (as per Article 13(2) & Article 14(2)) be carried out remotely or be conducted virtually?
While the MDR does not specify how verification checks should be carried out, the practical application of the MDR would allow importers to conduct verification checks virtually/remotely provided they fulfil the obligations outlined under Article 13 in full. Importer verification checks must be independent of any other checks conducted by economic operators such as the manufacturer, authorised representative or distributor. HPRA best practice guidance would require the importer to conduct a physical check on the device when first making the products available on the market. Following this physical check, a sampling basis could be introduced provided it is documented and justified and incorporates a risk based approach taking the device classification into consideration.
5) Can Importers conduct their checks/verifications on a sampling basis?
While Article 13 of the MDR does not specify how verification checks should be conducted, we acknowledge that physical checks of each individual device would not be a feasible approach. Our position at this time is that a risk-based approach should be taken to such checks and verifications, and these should be documented and conducted in accordance with an appropriate quality management system (QMS). The risk class of the devices should be taken into account when developing the sampling method and justification.