AAP IMPLANTATE

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

EQS-News: aap Implantate AG / Key word(s): Regulatory Approval/Miscellaneous
Progress in the MDR process - aap receives MDR certificate

27.01.2025 / 14:00 CET/CEST
The issuer is solely responsible for the content of this announcement.


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. 

 

----------------------------------------------------------------

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

 

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:



27.01.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at -news.com


Language: English
Company: aap Implantate AG
Lorenzweg 5
12099 Berlin
Germany
Phone: +49 (0) 30 75 019-0
Fax: +49 (0) 30 75 019-111
E-mail:
Internet:
ISIN: DE000A3H2101
WKN: A3H210
Listed: Regulated Market in Frankfurt (General Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2075379

 
End of News EQS News Service

2075379  27.01.2025 CET/CEST

fncls.ssp?fn=show_t_gif&application_id=2075379&application_name=news&site_id=research_pool~~~9efe1c65-8ece-4ff7-9608-f21c8e0a38a3
EN
27/01/2025

Reports on AAP IMPLANTATE

 PRESS RELEASE

EQS-News: Fortschritte im MDR-Prozess – aap erhält MDR-Zertifikat

EQS-News: aap Implantate AG / Schlagwort(e): Zulassungsgenehmigung/Sonstiges Fortschritte im MDR-Prozess – aap erhält MDR-Zertifikat 27.01.2025 / 14:00 CET/CEST Für den Inhalt der Mitteilung ist der Emittent / Herausgeber verantwortlich. Die aap Implantate AG („aap“ oder „Gesellschaft“) konnte einen weiteren wichtigen Meilenstein in Richtung Übergang von MDD (Medical Device Directive 93/42/EWG) hin zur MDR (Medical Device Regulation EU 2017/745) erreichen und im Anschluss an das im September 2024 erfolgreich durchgeführte Audit mit ihrer Benannten Stelle das MDR-Zertifika...

 PRESS RELEASE

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

EQS-News: aap Implantate AG / Key word(s): Regulatory Approval/Miscellaneous Progress in the MDR process - aap receives MDR certificate 27.01.2025 / 14:00 CET/CEST The issuer is solely responsible for the content of this announcement. 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 devic...

 PRESS RELEASE

EQS-News: Deutliche Fortschritte in allen operativen Bereichen; stabil...

EQS-News: aap Implantate AG / Schlagwort(e): Vertriebsergebnis Deutliche Fortschritte in allen operativen Bereichen; stabiles viertes Quartal führt zu 12.2 Mio. EUR Jahres-Umsatz (+6%) 24.01.2025 / 07:00 CET/CEST Für den Inhalt der Mitteilung ist der Emittent / Herausgeber verantwortlich. Die aap Implantate AG („aap“ oder „Gesellschaft“) informiert, dass mit Abschluss eines stabilen vierten Quartals ein vorläufiges Umsatzwachstum von 6,3% gegenüber dem Vorjahr erzielt werden konnte. In sämtlichen Regionen - bis auf die USA - wurde ein Wachstum erreicht. Die Investition in...

 PRESS RELEASE

EQS-News: Significant progress in all operating areas; stable fourth q...

EQS-News: aap Implantate AG / Key word(s): Sales Result Significant progress in all operating areas; stable fourth quarter leads to annual sales of EUR 12.2 million (+6%) 24.01.2025 / 07:00 CET/CEST The issuer is solely responsible for the content of this announcement. aap Implantate AG ("aap" or "Company") informs that with the end of a stable fourth quarter a preliminary sales growth of 6.3% compared to the previous year could be achieved. Growth was achieved in all regions except the USA. The investment in further aap systems to equip customers characterized the produc...

 PRESS RELEASE

EQS-News: aap informiert über die Einladung zur Hauptversammlung am 15...

EQS-News: aap Implantate AG / Schlagwort(e): Hauptversammlung aap informiert über die Einladung zur Hauptversammlung am 15. Januar 2025 09.12.2024 / 07:30 CET/CEST Für den Inhalt der Mitteilung ist der Emittent / Herausgeber verantwortlich. Die aap Implantate AG („aap“ oder „Gesellschaft“) informiert über die heute veröffentlichte Einladung zur Hauptversammlung, die am 15. Januar 2025 in Präsenz am Hauptsitz der Gesellschaft in Berlin stattfinden wird. Vorstand und Aufsichtsrat werden der Hauptversammlung insbesondere den nun festgestellten Jahresabschluss, den gebilligt...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch