a person responsible for regulatory compliance (PRRC) – at their disposal, to ensure the company is meeting certain specific EU requirements. The role of the PRRC is to ensure the compliance of released devices, as well as the postmarket surveillance (PMS) and vigilance activities concerning those devices (MDR recital 34, IVDR recital 33). Moreover, where a manufacturer is located outside the EU and an authorised representative (AR) is required, a secondary control is expected to be conducted by the PRRC of the AR in order to verify regulatory compliance of the devices produced by those manufacturers.
Both the manufacturers and the AR are required by MDR/IVDR Article 15 to have within their organisation, or at their disposal, at least one PRRC who possesses the required expertise and qualifications in the field of medical devices or in vitro medical devices, as applicable, in the EU. The responsibilities, qualifications and professional experience of the PRRC are also set in the regulations and interpreted in the MDCG Guidance 2019-7. As a manufacturer, operating a comprehensive quality management system (QMS) is not a new requirement in the regulations of medical devices. However, the IVDR specifies what the QMS must include and how the manufacturer must operate it. There are also new roles introduced, like the PPRC. Manufacturers must establish this new role, meeting requirements such as ensuring the chosen person has at least four years of expert knowledge in the field of IVD devices.
Maintain surveillance and vigilance Maintaining a post-market surveillance (PMS) in alignment with the requirement of the vigilance system are integral parts of any IVDR-compliant QMS, and are key in establishing robust systems and long-term quality and regulatory success. These are important elements that revolve around maintaining quality, performance and safety throughout the product life cycle. As the IVDR replaces the IVDD in 2022, there are many significant changes that IVD manufacturers must consider from a risk management perspective, as well as those pertaining to PMS to meet compliance requirements. Article 10(8i) states that a PMS system must be created and implemented and Article 10(9) states that this system must be kept up-to-date in accordance with Article 78. PMS programmes should actively and systematically gather information from a device in a way that allows for regular updates to technical documentation and competent authorities’ communication in the areas of vigilance and market surveillance. The date of application is fast approaching, and if manufacturers are not already in the process of preparing for the transition, the sooner they start, the better. ●
Medical Device Developments /
www.nsmedicaldevices.com MMI049_mdi
consultants.indd 1 04/10/2021 11:38
mdi Consultants, Inc. The Global Regulatory Experts
Over 44 years’ experience, assisting companies worldwide successfully enter and obtain approval to market in the United States, Europe and Canada.
We offer the following services:
• Provide FDA Regulatory Strategies • FDA/QSR/cGMP & ISO Compliance • Pre-Sub/510(k)/DeNovo/PMA submissions (over 4,000 successful submissions) • MDSAP (Medical Device Single Audit Program) - quality system implementation and certifi cation audit preparation • On-site Third Party Audits for ISO/MDSAP/ Mock FDA Audits • Device 513(g) requests for classifi cation • Health Canada MDEL and MDL assistance • FDA CRISIS INTERVENTION – (dealing with FDA inspections, FDA-483 & warning letter responses and mediation)
• US Agent and Offi cial Correspondent services • FDA Electronic Device Facility Registration and Device Listing • FDA Electronic Drug Facility Registration and Drug Listing • FDA Electronic Food Establishment Registration • e-MDR (Medical Device Reporting) fi ling • Unique Device Identifi cation (UDI) assistance
• Label Review – Devices, OTC Drugs, Dietary Supplements, Food Products and Cosmetics
• Off/On-Site FDA Training Courses in - Understanding FDA and QSR compliance - Intro to Design Control - Understanding CAPA •US Reimbursement services
mdi Consultants acts as an Offi cial
Correspondent and U.S. Agent for more than 400 International companies, provides initial Importer and distributor assistance, sales force performance improvement and marketing assistance.
Tel: +1 516-482 9001
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www.mdiconsultants.com
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