# TEAM-PRRC ## Pages - [Etn Category](https://team-prrc.com/etn_category/) - [Subcriptions](https://team-prrc.com/subcriptions/) - [Links ROME 2025](https://team-prrc.com/links-rome-2025/) - [Webinars upcoming](https://team-prrc.com/webinars-upcoming/) - [Webinars Open to Public](https://team-prrc.com/webinars-public-team-prrc/): Navigating the EU AI Act: Practical Compliance Implications for PRRCs - [Thank you for registering](https://team-prrc.com/thank-you-for-registering/): Your entry has been processed ! Thank you - [Events](https://team-prrc.com/event-directory/): [add_eventon] - [My account](https://team-prrc.com/my-account-2/) - [Checkout](https://team-prrc.com/checkout/) - [Cart](https://team-prrc.com/cart/) - [Our Webinars](https://team-prrc.com/events-public/) - [event-pro](https://team-prrc.com/event-pro-2/) - [Events - Zoom](https://team-prrc.com/events-zoom/) - [event-tab](https://team-prrc.com/event-tab/) - [event-pro](https://team-prrc.com/event-pro/) - [Events Members](https://team-prrc.com/events-members/) - [Etn Tags](https://team-prrc.com/etn-tags/) - [Événements](https://team-prrc.com/evenements/) - [Reset your password](https://team-prrc.com/reset-your-password/): Your password has been send by your mail ! - [Upcoming Webinars](https://team-prrc.com/webinars-zoom/) - [WATCH](https://team-prrc.com/watch/): Through the partnership we have with MDLaw, the leading database on European MDR and IVDR legal and regulatory information, we kindly invite you to follow their regulatory updates to stay informed about the latest developments and changes in the industry. You can also follow directly them on www.mdlaw.eu to discover their regular updates and ensure you remain compliant with the latest regulatory requirements. Please refer to www.mdlaw.eu/news to follow the Regulatory Watch - [My Space](https://team-prrc.com/my-space/) - [Member Directory](https://team-prrc.com/member-directory/): [ihc-list-users num_of_entries =’500′ entries_per_page =’50’ order_by =’last_name’ order_type =’asc’ user_fields =’user_email,first_name,last_name,ihc_avatar,ihc_sm,Your_activity,LinkedIn’ include_fields_label =’1′ theme =’ihc-theme_8′ color_scheme =’0a9fd8′ columns =’5′ align_center =’1′ show_search_filter =’1′ general_pagination_theme =’ihc-listing-users-pagination-1′ pagination_pos =’top’ exclude_pending =’1′ ] - [What you benefit from](https://team-prrc.com/what-you-benefit-from/): All that members benefit from : From Toxi Plan: a trusted service provider company for toxicology and biological safety requirements. Toxi Plan, is a referent company which helps MD manufacturers in their toxicology documentation demonstrating compliance with biological safety requirements. TEAM-PRRC member promotion: 5% on all services proposed by Toxi Plan with the promo code : MEMBER-PRRC%5 https://www.toxiplan.com/contact From MDlaw.eu: Subscription to regulatory affairs templates and other relevant documents. MDLaw.eu, a referent platform which helps you to identify and monitor relevant regulatory requirements and related changes. MDlaw annual membership: 30eur – 90 eur – 230eur TEAM-PRRC member promotion: 50% on all […] - [Webinars](https://team-prrc.com/webinars/): Navigating the EU AI Act: Practical Compliance Implications for PRRCs March 17th, 2026 presented by Maarten ten Mors Ask us Anything About The Proposal For A Regulation Amending The MDR & IVDR February 5th, 2026 presented by Dr. Bassil AKRA The responsibilities of the PRRC along the Economic Operator Chain November 27th, 2025 presented by Leon DOORN Biocompatibility & Toxicology Under MDR/IVDR: What Every PRRC Needs to Know October 20th, 2025 presented by Manon AVERSENG Translation Under the MDR and IVDR: What a PRRC Should Know September 23th, 2025 presented by Josh GAMBIN All you need to know about VIGILANCE as PRRC For registration, go to […] - [TEMPLATES and POSITION PAPERS](https://team-prrc.com/templates-position-papers/): Position papers : Templates : Dutch MDR violation penalties : Guide : Translation & Medical Devices – AbroadLink - [Newsletters](https://team-prrc.com/newsletters-2/) - [Useful Links](https://team-prrc.com/useful-links/): REGULATION (EU) 2017/745 on medical devices Regulation – 2017/745 – EN – Medical Device Regulation – EUR-Lex Link to EUR-Lex …1st/corrigendum/R745 Link to EUR-Lex …2nd/corrigendum/R745 REGULATION (EU) 2017/746 on in vitro diagnostic medical devices Link to EUR-Lex … R746 Link to EUR-Lex …1st/corrigendum/R746 Link to EUR-Lex …2nd/corrigendum/R746 Guidances BSI White paper: PRRC – MDR/IVDR Article 15 : MEDDEV Guidances : MDCG Guidances : Link to EU docsroom Link to EU docsroom Link to EU docsroom European Commission Guidance : The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations : link to European Commission Guidance […] - [Administrative documents](https://team-prrc.com/administrative-documents/): Statutory and Reference Documents TEAM-PRRC Association head office:38 rue des Mathurins75008 PARISFRANCE ✉ : contact@team-prrc.com Statutory Documents : Bank Account : Other Documents : General Assembly Meetings 2022 and 2023 : - [Error](https://team-prrc.com/error/): An error has occurred, please contact the association to resolve the problem ! - [Forum](https://team-prrc.com/community/): You can also ask your questions or share your experience in the private LinkedIn closed group with the link. - [Cloud TEAM-PRRC](https://team-prrc.com/cloud-team-prrc/) - [Memory Book](https://team-prrc.com/memory-book/) - [Membership Card](https://team-prrc.com/membership-card/) - [Member space](https://team-prrc.com/members-space/): FORUM ADMINISTRATIVE DOCUMENTS WATCH USEFUL LINKS WHAT YOU BENEFIT FROM  WEBINARS NEWSLETTER TEMPLATE AND POSITION PAPERS MEMBER DIRECTORY WEBINARS TO COME - [Sign-in](https://team-prrc.com/sign-in/): [ihc-login-form] - [JOIN US - MEMBERSHIP](https://team-prrc.com/how-to-join/): Who may join TEAM-PRRC ? All persons who comply with the requisite expertise listed in the article 15 §1 of the MDR and the IVDR may become a member of TEAM-PRRC. When you become a member of TEAM-PRRC, you automatically approve the Statutes of TEAM-PRRC, the internal regulations and the code of ethics. And, you have the voting rights during the General Assembly. Benefits of Membership The members can benefit from : Membership Fees : The membership fees is fixed to 250 € per year. It can only be paid by credit card, or exceptionally by bank transfer (please contact our treasurer for […] - [Compte Donateur](https://team-prrc.com/compte-donateur/) - [Default Redirect Page](https://team-prrc.com/default-redirect-page/): Redirected - [Public Individual Page](https://team-prrc.com/public-individual-page/): [ihc-visitor-inside-user-page] - [Terms and conditions](https://team-prrc.com/member-tos-page/): HOSTINGER Host Domain and Website builder solutionTEAM-PRRC uses HOSTINGER for hosting its activities (Hostinger International Ltd.,Cyprus private limited company, registered address 61 Lordou Vironos str., 6023 Larnaca,Cyprus).HOSTINGER undertakes in its Terms of service to guarantee the confidentiality of PersonalData processed under their Privacy Policy. Read the HOSTINGER Terms of service.TEAM-PRRC does not have access to the HOSTINGER cookies policy and cannot modify it.HOSTINGER declares to be hosted by © 2004-2025 hostinger.co.uk – United Kingdom –Premium Web Hosting, Cloud, VPS, AI Website Builder & Domain Registration Services. Personal data:No personal data is collected by TEAM-PRRC to navigate the public part of […] - [Welcome to TEAM-PRRC](https://team-prrc.com/thank-you-page/): [ihc-thank-you-page] - [Checkout Page](https://team-prrc.com/checkout-page/) - [Welcome Team-PRRC](https://team-prrc.com/subscription-plan/): Welcome to the registration page to become a member of Team-PRRC. We invite you to join our dynamic and passionate community. By registering, you will gain access to valuable resources and a support network that will help you progress on your journey. How to register Simply fill in the registration form available on our website. Once registered, you will be able to access your personal account, where you will find all the information you need to complete your membership and take full advantage of our offers. Subscription After registering, an annual subscription is required to enjoy the benefits of our […] - [Lost Password](https://team-prrc.com/lost-password/) - [Register](https://team-prrc.com/register/): [ihc-register] After registering, an annual subscription is required to enjoy the benefits of our team. The subscription fee is €250, which will give you access to exclusive services and events reserved for members. This fee contributes to the development of our initiatives and the continuous improvement of our organisation. - [Member LogOut](https://team-prrc.com/member-logout/): Thank you for visiting the Team-PRRC member area. To log out, please click on the button below. - [Member Login](https://team-prrc.com/member-login/): Please log in to access the site’s private content. [ihc-login-form] - [My Account](https://team-prrc.com/my-account/): [ihc-user-page] - [Contact](https://team-prrc.com/contact/): Contactez-nous Assistance Contactez-nous Nous sommes basés en Europe. Adresse 697 Hilltop Street, Springfield, MA, USA Localisation 9am – 6pm Contactez-nous Pour toute question concernant la conformité réglementaire, n’hésitez pas à nous contacter. Nous sommes là pour vous aider. - [Services](https://team-prrc.com/services/): Services de conformité Nous offrons des services spécialisés pour accompagner les professionnels dans la conformité réglementaire. Conformité Réglementaire Assurée Profession PRRC Établie Notre association soutient les professionnels de la conformité réglementaire, offrant des ressources et des formations pour garantir la conformité avec les règlements européens sur les dispositifs médicaux. Formation Spécialisée PRRC Nous proposons des programmes de formation adaptés aux exigences des règlements (UE) 2017/745 et (UE) 2017/746, afin de préparer les professionnels aux défis de la conformité réglementaire. Ressources Inestimables PRRC Accédez à une variété de ressources, y compris des guides, des études de cas et des outils pratiques, […] - [A Propos](https://team-prrc.com/a-propos/): Notre Mission L’association européenne dédiée à la profession de personne responsable de la conformité réglementaire. Engagement envers l’excellence Promouvoir la conformité réglementaire dans le secteur des dispositifs médicaux. Notre Histoire Notre Histoire Projets Innovants PRRC Initiatives de Conformité Nous développons des projets visant à promouvoir la profession de personne responsable de la conformité réglementaire, en conformité avec les règlements européens sur les dispositifs médicaux. Collaboration et Partenariats Nous collaborons avec divers acteurs du secteur pour renforcer la compréhension et l’application des normes de conformité, garantissant ainsi la sécurité et l’efficacité des dispositifs médicaux en Europe. Formation et Sensibilisation Nous offrons […] - [Events](https://team-prrc.com/program/): EVENTS TO COME PAST EVENTS Rome 2025 – 23 & 24 oct. 2025 Rome brought us together, inspired us and reminded us why TEAM-PRRC keeps growing stronger. Endless thanks to our sponsors, speakers and every member who made this event exceptional. Malaga 2024 – 17 & 18 oct. 2024 The association, which strengthened its position in the MedTech sector, held its third TEAM-PRRC Annual Summit in Málaga, Spain, on October 17 and 18, 2024. The event brought together key players in the medical device sector, such as the MDCG, competent authorities, notified bodies, lawyers, MD and IVD manufacturers, as well […] - [Our Team](https://team-prrc.com/ourteam/): The Board Elem AYNE President elem.ayne@team-prrc.com Anne JURY Vice – President anne.jury@team-prrc.com Bassil AKRA Vice – President bassil.akra@team-prrc.com Sandra FERRETTI Communication & Representative Lead sandra.ferretti@team-prrc.com René DROST Secretary rene.drost@team-prrc.com – Treasurer The Advisory Board Denys DURAND-VIEL Corinne DELORME David R RUTLEDGE The Representative PRRC Sandra FERRETTI for Belgium Annemieke VAN KERKWIJK for The Netherlands Piero COSTA for Italy José MALTA for Portugal Carmen MARTIN for Spain Ella HELGEMAN for Denmark Sanna M. MATTILA for Finland Michelle KEANE for Ireland Christopher KIPP for Germany Anne-Laure BAILLY for France Vladimir BURGIC for Serbia Jack WALTERS for UK Eric KLASEN for Switzerland Raje MARIKKANNU for […] - [News](https://team-prrc.com/news/) - [Regulatory & FAQ](https://team-prrc.com/about/): Links REGULATION (EU) 2017/745 on medical devices Regulation – 2017/745 – EN – Medical Device Regulation – EUR-Lex Link to EUR-Lex …1st/corrigendum/R745 Link to EUR-Lex …2nd/corrigendum/R745 Link to https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20250110 REGULATION (EU) 2017/746 on in vitro diagnostic medical devices Link to EUR-Lex … R746 Link to EUR-Lex …1st/corrigendum/R746 Link to EUR-Lex …2nd/corrigendum/R746 Link to https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20250110 MDCG GUIDANCE 2019-07 Rev.1 MDCG 2019-07 Rev.1 Guidance FAQ 1. What qualifications do I need to fulfil the role of PRRC for a medical device manufacturer ? Or 2. I have a degree (or diploma or other certificate) from a country outside of the EU.  Will this […] - [Home](https://team-prrc.com/): About US TEAM-PRRC was established in 2020 as a non-profit organization dedicated to the profession of « Person Responsible for Regulatory Compliance » (PRRC) according to Article 15 of the European Regulations on Medical Devices: MDR (EU) 2017/745 and IVDR (EU) 2017/746 : TEAM-PRRC is led by key subject matter experts who volunteered to support the implementation of the regulations (MDR & IVDR) by dedicating part of their time to this activity. Who we are ? A European association that aims to promote active compliance to MDR & IVDR A non-profit organization dedicated to the profession of “Person Responsible for Regulatory […] ## Products - [Subscription 1 year member TEAM-PRRC](https://team-prrc.com/product/subscription-1-year-member-team-prrc/): Subscription 1 year [comment]: # (Generated by Hostinger Tools Plugin)