为贵公司确定PRRC大多数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
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- As CE mark consultants for medical devices we’ll help you for the process of making a defined technical file with all the product details.
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We help you in the process of making a defined and comprehensive technical file with all product details required for CE marking.
Contact Us WhatsAppThe Regulations have a clear desire to add an additional level of scrutiny to the supervision and control of the manufacturing of medical devices, as well as relevant post-market surveillance and vigilance activities. Thus, Identifying the PRRC role is purposefully a sole position from the European Union Authorized Representative. The importance of Identifying the PRRC role by the MDR and IVDR goes beyond the role of a safety officer. While the EU MDR mandates to appoint a new figure in the organizational chart of an enterprise, has your organization considered how you will manage the role of the PRRC for regulatory compliance?
The right way of Identifying the PRRC is, if he’s responsible for the technical documentation EU Declaration of Conformity (drawn up and kept up-to-date), post-market surveillance obligations and checking the conformity of devices before they are released (according to the quality management system implemented).Each legal manufacturer must have its own PRRC. The PRRC must be close to the manufacturer, which means that if the manufacturer is located in the EU, its PRRC must also be located in the EU.
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
- 米edicine
- 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;
- 米aking 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.
The created role of PRRC will bring many challenges for manufacturers and regulatory specialist, and there is a lot at stake for those considering taking this role. The regulations mandate penalties that are decided on the level of the member states for noncompliance and individuals taking this role need to be aware of the potential consequences.