Aurena has completed the transition from MDD to MDR

Karlstad, Sweden: – Aurena Laboratories AB (Aurena) has completed its rapid transition of all its medical devices to meet the requirements of the EU’s new Medical Device Regulations 2017/745 (EU MDR), making its whole product range compliant more than 18 months ahead of the Brussels deadline.

Aurena’s product groups that are now MDR-approved include its wide range of saline/seawater nasal sprays, emollient sprays, burn gels, ear cleansing sprays, wound and eye wash sprays. According to the MDR, all these products are classified as medical devices class II a or b.

Regulatory achievement

This made Aurena an early company to move a complete range of products from the old MDD regulation to the new MDR regulation.

“This has been a huge task for the regulatory department and it is a great success for Aurena and its customers that we can continue to offer well-documented, safe, and effective products under the new regulation,” commented Aurena’s Director of Regulatory Affairs, Anders Bared.

Maintaining CE status

Aurena’s MDR certificate was issued by the Swedish Notified Body, Intertek, and is valid for four years from November 19, 2022. Although Aurena’s existing MDD certificate is valid until May 2024, new product launches will be under the MDR.

Published in 2017, EU MDR became operational for newly introduced products from May 2021 and will apply to all existing products from May 25, 2024. It replaces the previous Medical Devices Directive (93/42/EEC) (MDD) and the active implantable medical devices Directive (90/385/EEC) (AIMDD), which both expired on May 25, 2021. After the transition period to May 2024, no medical devices that were MDD CE-marked can be marketed in Europe.

About Aurena Laboratories

Swedish-based Aurena Laboratories (Aurena) specializes in the development and manufacturing of products using Bag-on-Valve packaging. The company is a leader in private label products and contract manufacturing of bag-on-valve aerosols for the pharmaceutical and medical device industry.

Their products offer private label seawater/saline-based nasal sprays, wound wash sprays, adhesive removers, emollient sprays and burn gels. Aurena-manufactured products are brought to market under Private Label or as contract-manufactured products.

More information is available at: www.aurenalabs.com

Resources

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