EQS-News: Progress in the MDR process - aap receives MDR certificate

aap Implantate AG ("aap" or "Company") has reached another important milestone in the transition from MDD (Medical Device Directive 93/42/EEC) to MDR (Medical Device Regulation EU 2017/745) and received the MDR certificate for its quality system following the successful audit with its Notified Body in September 2024.  The first medical devices Class IIa are also already MDR-certified, with further classes for plates and screws soon to follow.

The declaration of conformity for the first risk class is an important milestone towards full MDR certification of the entire portfolio. Compliance with the MDR is a prerequisite for the marketing of medical devices in the EU after the end of the transition period in 2028, but also for any placement of new products on the EU market. With this important milestone and the first positively reviewed technical documentation for its Class IIa products in accordance with the MDR, the company is continuing to work with its notified body to ensure a smooth and swift transition to MDR certification.

This important milestone makes the company confident that it will soon be able to expand its portfolio in the EU and focus more strongly on the development of new products. 

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aap Implantate AG (ISIN DE0005066609) - General Standard/Regulated Market - All German stock exchanges -

About aap Implantate AG

aap Implantate AG is a globally active medical technology company based in Berlin, Germany. The company develops, produces and markets products for traumatology. The IP-protected portfolio includes the innovative anatomical plate system LOQTEQ® and a wide range of cannulated screws. In addition, aap Implantate AG has an innovation pipeline with promising development projects such as antibacterial silver coating technology and magnesium-based implants. These technologies address critical problems in traumatology that have not yet been adequately solved. In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups and group clinics, while internationally it primarily uses a broad network of distributors in around 25 countries. In the United States, the company and its subsidiary aap Implants Inc. rely on a sales strategy via distribution agents and selective direct sales. The aap Implantate AG share is listed in the General Standard of the Frankfurt Stock Exchange (XETRA: AAQ.DE). For further information, please visit our website at www.aap.de.

The figures presented in this press release may be subject to technical rounding differences that do not affect the overall picture.

Forward-looking statements

This release may contain forward-looking statements that are based on the current expectations, assumptions and forecasts of the Executive Board and information currently available to it. The forward-looking statements are not to be understood as guarantees of the future developments and results mentioned therein. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual results, financial situation, development or performance of the company and the estimates given here. These factors include those that aap has described in published reports. Forward-looking statements therefore speak only as of the date on which they are made. We assume no obligation to update the forward-looking statements made in this release or to adapt them to future events or developments.

If you have any questions, please contact: aap Implantate AG; Rubino Di Girolamo; Chairman of the Management Board/ CEO; Lorenzweg 5; 12099 Berlin

Phone : +49 (0)30 75019 - 141; Fax: +49 (0)30 75019 - 170; Email: r.digirolamo@aap.de