EQS-News: aap successfully completes MDR certification: All existing products approved according to MDR – market access in the EU and CE-relevant markets secured in the long term

• MDR certificate for quality management system and Class IIa products received on
  January 27, 2025
• MDR certificate for the last product group (Class IIb) successfully issued – so that MDR certificates are available for all existing products

With the MDR certificate for Class IIb products, MDR certification is completed for all existing products

aap Implantate AG ("aap" or "Company") has received the MDR certificate for Class IIb products (plates and screws) from its Notified Body and has thus successfully completed the MDR certification process for all existing products. The transition from the previous MDD (Medical Device Directive 93/42/EEC) to the MDR (Medical Device Regulation (EU) 2017/745) is a prerequisite for the marketing of medical devices in the European Union after the expiry of the respective transition periods. With the completion of the MDR certification, the risk of missing the relevant transition periods for the existing portfolio is eliminated. At the same time, aap can secure market access in the EU as well as in CE-relevant markets in the long term. On this basis, the company is once again focusing more strongly on the further development of the portfolio and the introduction of new products. The first further developments of the LOQTEQ® product family are to be launched in the second half of 2026 and will provide positive impact for sales development from 2027 onwards.

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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 global medical technology company headquartered in Berlin. The company develops and markets products for traumatology. In addition to the innovative anatomical plate system LOQTEQ®, the patent-protected portfolio includes a wide range of perforated screws. In addition, aap Implantate AG has an innovative pipeline of promising development projects, such as an antibacterial silver coating technology. This technology addresses critical and so far insufficiently solved problems of wound infections after surgery (SSI) in traumatology and is also applicable in other medical technological areas. In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups and affiliated clinics. Internationally, it mainly uses a broad network of distributors in around 41 countries. In the USA, the company and its subsidiary aap Implants Inc. rely on a network of agents and a selective direct sales strategy. The shares of aap Implantate AG are listed in the General Standard of the Frankfurt Stock Exchange (XETRA: AAQ.DE). For more information, please visit our website at www.aap.de.

There may be technical rounding differences in the figures presented in this press release, which do not affect the overall statement.

Forward-Looking Statements

This release may contain forward-looking statements based on the current expectations, assumptions and forecasts of the Management Board and information currently available to it. The forward-looking statements are not to be understood as guarantees of future developments and results referred to therein. Various known and unknown risks, uncertainties and other factors could cause the actual results, financial condition, development or performance of the Company to differ materially from the estimates given herein. These factors also include those described by aap in published reports. Forward-looking statements therefore speak only as of the date on which they are made. We undertake no obligation to update the forward-looking statements made in this release or to conform them to future events or developments.

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

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