ARDS Industries Ltd. – website www.ardsimplants.com and electronic instructions for use portal www.ai-ifu.com
Version 1.0- effective date: 27.09.2026
This policy explains how ARDS Industries Ltd. ("ARDS", "we", "us") processes personal data when you visit www.ardsimplants.com, access our electronic instructions for use (eIFU) through www.ai-ifu.com, or contact us. It is provided in accordance with Articles 12 to 14 of the General Data Protection Regulation (EU) 2016/679 ("GDPR") and Article 7(2)(d) of Commission Implementing Regulation (EU) 2021/2226 on electronic instructions for use of medical devices.
Controller
ARDS Industries Ltd.
POB 6762, Petah Tikva 4934829, Israel
Phone: +972 4 381 2333
Privacy contact
E-mail: info@ardsimplants.com
Post: as above, marked "Privacy"
Representative in the EU (Art. 27 GDPR)
AR Expert B.V Boeing Avenue 209, 1119 PD Schiphol-Rijk, The Netherlands Tel: +31(0)85-007-3210 info@certification-experts.com
Data protection officer
ARDS has not appointed a data protection officer, as the conditions of Art. 37 GDPR do not apply. Privacy questions can be sent to the privacy contact above to info@ardsimplants.com
You can view and download our instructions for use without registering, logging in or providing your name or contact details. The region, product category, language and REF (catalogue) number you select or enter are used only to show you the correct documents and are not linked to your identity.
Instructions for use are provided as PDF files that can be opened with any free PDF reader. Downloading a PDF does not send personal data to ARDS beyond the technical data described in section 3.1.
Data
IP address, date and time of the request, page or file requested, browser type and version, operating system, referring page, and the HTTP status of the request.
Purpose
To deliver the website and the instruction files to your device, to keep the service secure and available, to protect the instruction files against unauthorized modification, and to investigate faults and attacks. The last three purposes are also required by Article 7(2)(b) and (c) of Regulation (EU) 2021/2226.
Legal basis
Art. 6(1)(f) GDPR – our legitimate interest in operating a secure and available website and eIFU service.
Retention
Server logs are kept by our hosting provider for 1 day and then deleted, unless they are needed to investigate a specific security incident.
You can request a paper copy of any of our instructions for use free of charge. We send it within 7 calendar days of receiving the request. If you ask for it when you place your order, we deliver it with the device. To request a copy, e-mail- info@ardsimplants.com, call +972 4 381 2333, or contact your local ARDS distributor.
Data
Name, clinic or organization, delivery address, e-mail address, telephone number, and the product (REF number, lot number) and language requested.
Purpose
To send you the paper copy and to keep a record that the request was fulfilled.
Legal basis
Art. 6(1)(c) GDPR – legal obligation under Article 5(3) of Regulation (EU) 2021/2226 to supply a paper copy on request.
Retention
15 years after the request, in line with ARDS's quality-record retention procedure.
Is the data required?
Yes. Without a name and delivery address we cannot send the paper copy.
Data
Name, organization, contact details and the content of your message.
Purpose
To answer your enquiry and, where relevant, to handle orders and the business relationship.
Legal basis
Art. 6(1)(b) GDPR, where the enquiry relates to a contract or steps before a contract; otherwise, Art. 6(1)(f) GDPR, our legitimate interest in answering enquiries.
Retention
Up to 15 years after the enquiry has been closed, or longer where required by commercial or tax law.
If you report a complaint, a malfunction or an incident involving an ARDS device, we process the information needed to investigate it and to meet our obligations as a medical device manufacturer.
Data
Reporter's name, organization and contact details. Details of the device (REF, lot) and of the event. Where necessary for the investigation, limited information about the patient, such as age, sex, the clinical course and the treatment given. This may include health data.
Purpose
Complaint handling, post-market surveillance, and vigilance reporting to competent authorities and our notified body.
Legal basis
Art. 6(1)(c) GDPR – legal obligations under Regulation (EU) 2017/745 (MDR), in particular Articles 10, 83 and 87. For health data: Art. 9(2)(i) GDPR- reasons of public interest in ensuring high standards of quality and safety of medical devices.
Retention
For the period required by the MDR for the technical and post-market surveillance documentation: at least 15 years after the last device of the type concerned has been placed on the market.
Please do not send us the patient's name or other directly identifying details. Use a case or patient code instead. If identifying details are received, we pseudonymize them.
Our website contains links to our pages on Facebook, Instagram, LinkedIn and X (Twitter). These are plain links: no data is sent to these platforms until you click a link. After you leave our website, the privacy policy of the platform applies.
Our website uses only cookies and similar technologies that arestrictly necessary to provide the service you request, such as remembering your region and language selection. These do not require your consent (Article 5(3)of Directive 2002/58/EC). We do not use analytics, advertising or tracking cookies.
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Cloudflare
Distinguishes individual visitors sharing the same IP address, to apply security/rate-limiting protections against malicious traffic
Session
· Website hosting: Webflow, Inc., USA, and its content-delivery sub-processors host the website and the instruction files. They act as our processor under a data processing agreement.
· E-mail and IT services: Google Ireland Limited (Google Workspace), acting as our processor.
· ARDS distributors: where a distributor delivers the paper copy or handles your enquiry in your country.
· Authorities and our notified body: competent authorities and our notified body, where required for vigilance and post-market surveillance under the MDR.
· Professional advisers and courts: where necessary to establish, exercise or defend legal claims.
We do not sell personal data, and we do not use it for advertising.
ARDS is established in Israel. The European Commission has recognized that Israel provides an adequate level of data protection (Commission Decision 2011/61/EU), so no additional safeguards are needed for transfers from the EEA to ARDS.
Where data is transferred to serviceproviders in the USA or other third countries, we rely on one of two safeguards:
· the EU–U.S. Data Privacy Framework, where the recipient is certified; or
· otherwise, the Standard Contractual Clauses adopted by the European Commission (Implementing Decision (EU) 2021/914), with supplementary measures where needed.
You can request a copy of these safeguards from the privacy contact.
The website and the eIFU portal are delivered only over encrypted connections (HTTPS/TLS). Instruction files are uploaded only by authorized ARDS personnel under our document-control procedure and are verified against the controlled master copy before publication. Access to personal data is limited to the staff who need it for the purposes above.
Under the GDPR you have the right to:
· access your personal data and receive a copy (Art. 15);
· have inaccurate data corrected (Art. 16);
· have your data erased (Art.17);
· restrict processing (Art. 18);
· receive data you provided in a portable format (Art. 20);
· object at any time to processing based on our legitimate interest (Art. 21);
· withdraw consent at any time,where processing is based on consent (Art. 7(3)).
Some of these rights are limited where we must keep data to meet a legal obligation, for example vigilance records under the MDR.
To exercise your rights, contact the privacy contact in section 1. We answer within one month; this can be extended by two further months for complex requests, in which case we will tell you. We may ask you to confirm your identity.
You also have the right to lodge a complaint with a data protection supervisory authority (Art. 77 GDPR). You can do this in particular in the EU Member State where you live or work, or where you believe the infringement took place. The list of authorities is available at edpb.europa.eu.
We do not make decisions based solely on automated processing, including profiling, that have legal or similarly significant effects on you.
Our website and instructions for use are intended for dental professionals. They are not directed at children, and we do not knowingly collect data from children.
We review this policy when our processing changes, and at least once a year. The current version and its effective date are shown at the top of this page. Previous versions are available on request from the privacy contact.
