Aurena moves from MDD to MDR

Karlstad, Sweden: – Aurena Laboratories AB (Aurena) is transitioning all its CE-marked medical devices to meet the requirements of the EU’s new Medical Device Regulations 2017/745 (EU MDR) and plans to make its whole product range compliant by the end of 2022.

This would make Aurena one of the faster-moving companies in Europe in the move from the old MDD regulations to the new MDR code and has involved intense efforts by the Swedish-based saline and innovative delivery specialist to ensure all its CE-labeled products comply with the new directive.

Deadline 2024

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 the May 2024 deadline, no medical devices that were CE-marked under the MDD regime can be marketed in Europe.

Rapid transition

“Our clients – existing and potential – who market medical devices can have confidence that Aurena’s products will soon meet MDR requirements to be CE-marked. This applies, for example, to our range of nasal sprays including Sparkling Saline Sprays, which are unique products from Aurena,” explained Aurena co-founder and Director of Business Development, Magnus Hedman.

Regulatory changes

The European Union Medical Device Regulations 2017/745 (commonly known as the EU MDR) were originally published in 2017 and outline the requirements for CE Mark compliance. All medical devices sold in Europe will need to obtain CE Marking from an accredited Notified Body prior to being placed on the market.

The EU MDR supersedes the previously enforced regulations: the Medical Device Directive (MDD) and the Active Implantable Device Directive (AIMD). Beginning May 26, 2021, all new CE Marked products had to show compliance to the EU MDR while existing medical devices have until May 25, 2024 to transition to the new compliance requirements.

Aurena at CPhI Wordwide

Come and visit Aurena’s booth 91F60 at CPhI Worldwide in Frankfurt 1-3 November 2022.

The Aurena teams at CPhI are accepting requests to book face-to-face meetings to discuss topics such as contract fill and finish services, and marketing of products from Aurena’s large private label portfolio. Please send email to [email protected] to request a meeting.

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 gel. Aurena-manufactured products are also brought to market under Private Label or as contract-manufactured products.

The company complements its internal resources with external expertise and capabilities, including clinical development, product development and commercialisation.

More information is available at: www.aurenalabs.com

Resources

Click on Aurena CE-Marketing and Regulatory Support for further information.
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