The Person Responsible for Regulatory Compliance (PRRC) is a new and required by MDR 2017/745 and IVDR 2017/746 person for manufacturers of medical devices and their European Representatives. We provide a seasoned PRRC on a mandate to Small and Medium Sized Companies (SMEC’s).
The European Representative (EC REP) is required for non-EU based/EFTA/EEA medical device manufacturers as per MDR 2017/745 and in-vitro diagnostics as per IVDR 2017/746. We’re here to act as your EC REP within the EU for all class I, IIa, specific IIb and III medical devices as well as class A, B and specific Class C and D in-vitro diagnostic devices.
Regulatory Compliance Assessment
Is your company in need of a Person Responsible for Regulatory Compliance (PRRC)? We’re your knowledgeable PRRC for Medical Devices and In-Vitro Diagnostics. With our team of seasoned Quality and Regulatory Assurance staff, we assess your regulatory compliance and permanently monitor the continuously evolving regulations landscape, standards and guidelines against your processes and procedures.
We act as your PRRC and keep your regulatory compliance high. With our pragmatic approach, we understand business requirements and balance these against your compliance requirements. We hold knowledge, amongst others, in the following fields of medical technology:
- All class I medical devices
- All class IIa medical devices
- Syringes, Injectors, Auto-injectors
- Patch-Pumps, Inhalers, Electrical Equipment
- Implants, implantable polymers, ceramics, and advanced materials
- Active medical devices, such as pacemakers
- Software, AI-algorithms, and Apps
- All class A IVDs
- All class B IVDs
- Blood, urine, saliva and sweat screening.
- Biomarker detection and quantification for Cancer, Immunology, Cardiovascular, Diabetes, and Physiological Parameters.
Assessment for CE compliance
We assess your product range for compliance with European market regulations and CE markings. Any gaps discovered will be assessed and a guideline for gap closure will be provided. HEMEX can ensure your firm remains compliant with EU market regulations, enabling successful market access.
We are your EC REP based in Switzerland. HEMEX can manage your supply chain within the EU, can carry out audits on behalf of your importers, distributors or warehouses. We collate all feedback from the EU and monitor product safety, performance and usability to provide you with MDR/IVDR-compliant statistics on market feedback.