The free sale certificate is an essential document to expert medical devices. These are certificates that are aiming at facilitating the export of medical device and in-vitro diagnostic devices outside the European Union.
In the European Medical Device Regulation 2017/745, the certificate of free sale is regulated by Article 60 whereas for the In-vitro Diagnostic Device Regulation 2017/746, the FSC are mentioned in Article 55.
Within QualityMedDev website, we have been extensively talking about MDR and IVDR, covering different topics from post-market surveillance to technical documentation, or other important aspects such as legacy devices, requirements for implantable devices and the new IVD classification system, which actually chancing substantially the regulatory landscape of IVD devices.
In this article, we will discuss about the free sale certificate, going in details into the requirements mentioned in Article 60 of MDR and Article 55 of IVDR. It is however important to mention that two articles are quite the same and they are reporting exactly the same requirements and the same contents, with the differences being related to reference to other articles of the regulation that are different from MDR and IVDR.
What is a Free Sale Certificate
A free sale certificate allows to provide evidence that the medical device or IVD device are sold and distributed in the EU market with no restrictions and they are approved by the regulatory bodies in the countries of origin.
These certificates are very often requested during registration process of MD or IVF outside the European Union; in fact, very often for extra-EU countries the demonstration that the device is authorised to be sold and distributed in EU countries is already a demonstration of very good level of compliance, considering how strict and complex became the CE marking process under the EU MDR 2017/745 and IVDR 2017/746.
Who can ask for a Free Sale Certificate?
The certificate of free sale can be asked by a manufacturer or it authorised representative. We remind here the definition of authorised representative, as mentioned in the Article 2 of the Regulation:
any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this Regulation;
We remind as well that the authorised representative is mandatory for manufacturers which have their registered place of business outside the European Union and want to sell their devices in the European countries.
How to get a Free Sale Certificate
Manufacturers or their authorised representative can ask the free sale certificates to competent authorities of their registered place of business. In other words, if a manufacturer or authorised representative has the registered place of business in Italy, the free sale certificates shall be asked to the related competent authority, that is the Italian Minister of Health.
Which information shall be mentioned in the Free Sale Certificates
There is no standard template for a free sale certificate, thus the structure of these certificates may differ from competent authorities. However, Article 60 defines basic information that shall be included in the certificate. Specifically, it is mentioned:
The certificate of free sale shall set out the Basic UDI-DI of the device as provided to the UDI database under Article 29. Where a notified body has issued a certificate pursuant to Article 56, the certificate of free sale shall set out the unique number identifying the certificate issued by the notified body, as referred to in Section 3 of Chapter II of Annex XII.
This basically means that Basic UDI-DI of the device mentioned in the certificate shall be included; moreover, CE certificate issued by the notified body at the end of the certification process shall also be included in the certificate.
Despite the specific information being requested to be present in the specific certificate, when the request for a free sale certificate shall is performed to the authority, the following information shall be involved:
- Information about the device
- Name and form of the device
- Classification (according to EU regulation)
- Composition and description
- CE Certificate
- Information about the manufacturer
- Name and contact details
- Production Site
- Contact details for Notified body
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