Export Certification – 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 firstname.lastname@example.org. 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.
Due to the current public health pandemic, the offices of the HPRA are currently closed with limited access per week for members of the export certificates team to facilitate printing and wet signing of certificates. Therefore, all applications for certificates may face delays in processing.
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)
II. The Medical Devices Regulation which covers devices compliant with Regulation 2017/745 on medical devices (MDR)
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.
2. Application forms
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.
In-vitro Diagnostic Medical Devices (IVDs) that are in conformance with the IVDD.
Application for certificates for free sale (MDR compliant medical devices, system and procedure packs) 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)
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.