Specialisation in the pharmaceutical and cosmetics sectors: introduction and stages of importation
Medical devices must undergo a threefold check of legal requirements so that importation can be carried out with full legal and health guarantees. We can say that the importation process consists of the following stages:
Stage 1: before importation
It must be verified that:
- The Declaration of Conformity (DoC) meets all legal requirements set out in Regulation (EU) 2017/745.
- The labelling also meets all requirements set out in the regulation.
- The instructions for use contain the minimum information required by the regulation.
- If the medical device is Class I sterile or higher, it must also be verified that the CE certificates are in accordance with what is set out in the 2017/745 Regulation.
It is also important to bear in mind that the information contained in both the Declaration of Conformity and the CE certificates must match the information that must appear on the labelling and in the instructions for use.
For greater confidence in the information contained in the documentation, it can be verified via the European public access platform EUDAMED; on this platform, European national agencies verify that economic operators and products meet the legal guarantees required to market medical devices. To date, this is the best way to check that the data on products and in the documentation are accurate.
Stage 2: customs
- When the product arrives at customs, it must undergo a pharmaceutical inspection. In this inspection process, they will check that the DoC, labelling, instructions for use, and CE certificates comply with both national and European regulations.
- For this reason, it is essential to verify prior to importation that the information provided meets the legal requirements, both to avoid delays in clearance and to prevent potential customs and time-related costs.
- Once the information has been checked by the customs agent, confirming that it is correct in accordance with the regulation and that there are no inconsistencies or incorrect information, the product will proceed to customs clearance.
Stage 3: arrival of the product at the facilities
- When the order is correctly received at the importer’s facilities listed on the import licence, the final stage will take place: inspection of the product by the technical responsible person.
- Normally, the legal requirements to be verified by the technical responsible person will mainly relate to labelling and instructions for use, since the Declaration of Conformity and CE certificates have been verified previously. However, there are cases in which essential information may be missing from the labelling or instructions for use (e.g., a harmonised symbol or importer details), so this verification stage is essential to identify such potential deficiencies.
- Once this has been verified, the technical responsible person must decide on the release of the product, record the incident depending on the criticality of the deficiency, and decide whether or not the product will be placed on the market, always assessing the incident together with the manufacturer and, if necessary, with the European representative and the competent authority. If the release of the product is ultimately confirmed, the technical responsible person will proceed with its release and the product may then be marketed as normal. The record must be kept at the facilities for at least 10 years from the placing on the market of the last unit of the medical device.