The new Regulation on Medical Devices, MDR 217/745, enforced on May the 26th 2021, in all EU Countries, is replacing the Directive 93/42/EEC. The new MDR 2017/745 is increasing the obligations of the medical device stakeholders: manufacturers, mandatories, importers and distributors, healthcare professionals and end users.
Since the disposable gloves may be also used as a Class I Medical Device, we summarize here below some points of the new MDR 2017/745 regulation regarding the Distribution of Medical Devices that may interest you as customers and distributors of products with the Medical Devices CE marking.
TRACEABILITY
The traceability of the products supplied by Reflexx Company will be mandatory and therefore item codes, lot numbers and quantities will have to be registered, and, in the case of further re-distribution, with reference to the end user of the product.
POST-MARKET SURVEILLANCE
It will be required an obligation of surveillance and prompt information to the manufacturer/importer (Reflexx Company in our case) of any non-conformity noticed on the devices (gloves), as well as any complaints or other information from end users, regarding the product itself , its packaging or labelling.
In the case of non-compliance or complaints, prompt communication will be requested, with the indication of all data necessary for the identification of the products (code, batch, delivery date). If it is possible, we will also ask samples of the defective products and, in any case, to cooperate with our offices for the adoption of corrective actions, withdrawal or recall.
PRODUCT STORAGE
Compliance with the storage conditions displayed on the packaging will be required, i.e. storing the products in a clean and dry place, away from direct heat sources, away from weather conditions, in order not to compromise the quality.
