2017/745 Regulation (MDR) – Vitrobio Certification Update
Vitrobio is already committed to the transition to MDR. An application for certification under Annex XI part A of Regulation 2017/745 has been submitted to the GMED, for the entire product portfolio. Conformity assessment services are currently underway.
Vitrobio was audited in March 2023 by the GMED (Initial certification audit under the Regulation 2017/745). This on-site audit did not reveal any major non-compliance (0 major non-conformities). In parallel, the technical documentation for Vitrobio products is currently being assessed. Certification is conditioned by the conclusions of both on-site audit and documentary review. At this stage, we hope to obtain certification in mid-2024.
Vitrobio products benefit from the extended transition period. They can therefore be produced under certification in accordance with Directive 93/42/EEC (MDD) until 31/12/2028 and can then be kept on the market until they expire.
One certification does not cancel the other, so the same product can be manufactured under both directive and regulation certification at the same time.
Please note that HG-VB, indicated for the treatment of genital herpes, and formula VB-PHR-E, indicated for the treatment of sore throat in children, do not benefit from the transition period and will therefore no longer be manufactured after 26 May 2024.
2017/745 Regulation (MDR) – Impact for distributors
The requirements of Regulation 2017/745 have an impact on distributors’ obligations.
You will find details of your general obligations in Article 14 of Regulation 2017/745.
On the basis of Article 16 of Regulation 2017/745, with the aim of securing your status as a distributor, Vitrobio could be required to send you, if it has not already done and depending on your your distribution area, an amendment to your distribution contract in order to formalise the responsibilities of each of the parties.
In addition, it is important to be aware of Article 7 of Regulation 2017/745, which governs the design of packaging items and communication media. Vitrobio’s regulatory team will remain your point of contact and will provide the usual support for the design or change of your packaging items and communication media.
All products manufactured under MDR certification will have to bear a unique identification number that will be used to track the product (UDI), in compliance with Article 29 of Regulation 2017/745. When Vitrobio is indicated as the legal manufacturer on the packaging, Vitrobio assumes all the obligations of the manufacturer and is therefore responsible for the creation, management and registration of the UDI. The UDI codes will therefore be generated from Vitrobio’s own GTIN code. The UDI numbers must now be affixed to the secondary packaging of products manufactured under MDR certification. Vitrobio is currently in discussion with the GMED to decide whether the UDI should be affixed to the primary packaging from now on or from 26 May 2025 (in accordance with article 123.3 paragraph g).
Please note that products manufactured under MDR certification may have their packaging items slightly modified. The following data may be reviewed in accordance with the clinical assessment report submitted as part of the MDR certification:
- Age of the target population;
- Affixing of the UDI number;
- Removal of illustrations showing plants;
- -Wording of claims;
- -Wording of the indication.
You can be assured of Vitrobio’s support in implementing these changes.
We remind our distributors, who place our products on the market outside the European Union, that it is their responsibility to notify these changes to the national authorities of the countries concerned.