Certificate of Free Sale for Medical Devices

Certificates of free sale are documents used in the registration of devices in third countries (i.e. countries outside the European Economic Area). They indicate that the devices listed are compliant with EU legislation and may be sold in the EU market.

The HPRA currently issues certificates of free sale to economic operators that are established in Ireland. All applications must be submitted electronically to devices@hpra.ie. For more information, please see the Guide to Applications for Certificates of Free Sale for Medical Devices

For information regarding fees, please see the Guide to Fees for Human Products and Payment of Fees Instructions

1. Legal Basis 

The Health Products Regulatory Authority (HPRA) currently issues certificates of free sale under two legal frameworks:

I. The IMB Act which covers devices compliant with the following legislation:

a. Directive 90/385/EEC on active implantable medical devices (AIMDD)
b. Directive 93/42/EEC on medical devices (MDD)
c. Directive 98/79/EC on in vitro diagnostic medical devices (IVDD)
d. Regulation 2017/745 on medical devices (MDR), specifically for system and procedure packs)
e. Medical devices that fall under the MDR transitional provisions (MDR Article 120 (3)) 
f. In-vitro diagnostic medical devices that fall under the IVDR transitional provisions (IVDR Article 120(3) and amending Regulation 2022/ 112).

II. Medical Devices Regulations which cover devices compliant with:
a. Regulation 2017/745 on medical devices (MDR)
b. Regulation 2017/746 on in-vitro diagnostic medical devices (IVDR)

It should be noted that while the process for issuing certificates of free sale under each legal framework is similar, each legal framework has a specific application form.
Note: The appropriate legal basis for issuing the CoFS is dependent on the conformity assessment provisions under which the device is originally CE marked, e.g.  devices in conformance with the Directives will have a CoFS issued under the IMB Act.  Devices in conformity with the MDR/ IVDR will have a CoFS issued under the Regulations.

2. Application forms

2.1 The application for certificates for free sale (MDD medical devices, system and procedure packs, legacy devices) form should be used for:

  • Devices and system and procedure packs where the declaration of conformity has been drawn up before 26 May 2021 and the devices are placed on the market before 26 May 2021.

  • Devices that are in conformance with the Medical Device Directives (MDD or AIMDD) and can continue to be placed on the market until 2024 in accordance with Article 120(3) of the MDR.

  • Devices that are in conformance with the Medical Device Directives (MDD or AIMDD) but will be up classified under the MDR.

2.2 Application for certificates for free sale (In-vitro Diagnostic Medical Devices and legacy In-vitro Diagnostic Medical Devices) form should be used for: 

  • In-vitro Diagnostic Medical Devices where the declaration of conformity has been drawn up before 26 May 2022 and the devices are placed on the market before 26 May 2022,
  • devices that are in conformance with the In-vitro Diagnostic Medical Devices Directive (IVDD) and that can continue to be made available on the market in accordance Article 110 of the IVDR as amended by Regulation 2022/112
  • In-vitro Diagnostic Medical Devices that are in conformance with the In-vitro Diagnostic Medical Devices Directive (IVDD) but will be up classified under the IVDR.

2.3 Application for certificates for free sale (MDR compliant medical devices, system and procedure packs) form should be used for:

  • Medical devices compliant with Regulation 2017/745 (MDR).

  • System and procedure packs compliant the MDR.

2.4 Application for certificates for free sale (IVDR compliant medical device) form should be used for:

 

3.  Supporting documentation 

Depending on the type of device, the following documentation will be required:

  • Declaration of conformity

  • Conformity assessment certificate (CE Cert)

  • Full quality assurance certificate 

  • HPRA registration number or SRN

  • Proof of payment to the HPRA

  • Product codes (MDD/IVDD) / UDI(MDR/IVDR) 

  • Notified body certificate numbers and expiry dates

When applying for a certificate of free sale, proof of manufacture must be provided in the form of a letter. This letter is a statement made by the manufacturer on the company’s letter headed paper, signed by a designated representative. This is in addition to any proof of manufacture required from the notified body. 

The HPRA has developed a certificate of free sale checklist to assist with applications.