Identifying the PRRC for your company is a most important requirement that applies to the European Union and is a core area of responsibility for a person or persons under the Medical device regulation, or In vitro device regulation . The directive to appoint the PRRC also depends on the size of the organization. This is mandatory requirement for any CE Marking under the new EU MDR
The motivation for Identifying the PRRC positions is so that there is a qualified regulatory expert directly responsible for the manufacturing and the market surveillance and reporting systems to ensure the company is meeting the European Union requirements. Companies are not limited to one PRRC and the responsibilities can be allocated to several people, as long as the requirements concerning qualification are met and the distribution of the respective areas of responsibility are documented. If the responsibilities are divided among more than one person, ensure that all responsibilities are covered.
Identifying the PRRC
- He should have the right diploma,
- He should have 1 year of experience in regulatory affairs or quality management systems on medical devices.
For Identifying the PRRC what Diploma is required?
There is no fix choice but it should be a diploma in:
- Law
- Medicine
- Pharmacy
- Engineering
- Another Scientific Discipline
Identifying the PRRC Responsibilities
The PRRC has at least 5 responsibilities clearly outline in Article 15.
- Checking the conformity of medical devices in accordance with the quality management system (QMS) before the medical device is released;
- Drawing up the technical documentation and keeping it up to date;
- Making sure the post-market surveillance obligations are in compliance with EU regulations Article 10(9);
- Fulfilling the reporting obligations referred to in reporting of serious incidents and field safety corrective actions (Article 82) and implementing acts (Article 86)
- Ensuring the statement that investigational devices (Section 4.1 of Annex XIV) meet the GSPRs is signed.
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Mail id – enquiry@operonstrategist.com
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Phone no - 93702 83428
Mail id – enquiry@operonstrategist.com
If You Want Medical Devices Services Consultation For Following.- Medical Device Consulting
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- medical device process validation
- combination product
- continuous improvement program
- Medical Device Compliance & Regulatory Services
- Cdsco India authorized agent for medical device
- Medical Device Consulting
- cdsco registration
- FDA 510k Clearance
- ce mark medical device
- CDSCO Manufacturing License
- CDSCO import license
- TURNKEY PROJECT CONSULTANT
- medical device manufacturing
- iso 15378 certification
- 21 cfr part 210 and 211
- ISO 13485 Medical Device Consultant
- Primary Packaging Turnkey Project Consultant
- Clean Room Design Consultant
- manufacturing site conceptualization
- Market Analysis and feasibility for Medical Devices
- manufacturing plant layout design
- medical device design and development
- DMF file submission guideline
- 21 cfr part 820
- qms certification services
- capa management
- design control requirements
- medical device process validation
- combination product
- continuous improvement program
- Medical Device Compliance & Regulatory Services
- Cdsco India authorized agent for medical device
