NEW EUROPEAN REGULATION FOR MEDICAL DEVICES
MEDICAL DEVICE REGULATION (MDR)
The Medical Devices Regulation (EU) 2017/745 entered into force on 26 May 2021.
This regulation defines obligations throughout the supply chain, from the manufacturer to the end user.
By default the products distributed by VLAD are neither Medical Devices nor Medical Device Accessories within the meaning of Regulation (EU) 2017/745, unless indicated by the manufacturer brought to our attention.
The products of the EXALIUM Premium range, manufactured by VLAD, are not considered as Medical Device Devices or Accessories.
CASE OF DISTRIBUTED PRODUCTS IDENTIFIED AS ACCESSORIES AND MEDICAL DEVICES BY THE MANUFACTURER
VLAD undertakes to check the following points before distribution to resellers (Article 14):
- The accessory or medical device bears the CE marking and has an EU declaration of conformity,
- The labelling shall comply with Annex I Section 23, the device shall be accompanied by instructions for use,
- The accessory or medical device has a UDI identifier.
VLAD undertakes to apply and enforce with its resellers the storage conditions defined by the manufacturer as long as the accessory or device is under its responsibility.
Obligations and expectations
- Compliance with regulations,
- Traceability
- Storage and preservation conditions,
- Register of events, non-conformities, follow-up and recall,
- Integrity of the supplier's accessory or Medical Device.
VLAD undertakes to inform the supplier or its end customer without delay as soon as it becomes aware of an alleged incident (materialovigilance) related to a medical device or accessory marketed.
VLAD is registered as an operator with the EUDAMED database for medical devices.
The list of Medical Devices and Medical Device Accessories declared by manufacturers and distributed by VLAD is available on request: