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PRRC – Article 15: MDR (EU) 2017/745



Person Responsible for Regulatory Compliance


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MDR Article 15 - PRRC



Person Responsible For Regulatory Compliance



The Medical Device Regulation (MDR) (EU) 2017/745 came into effect on the 25th of May 2017 and as such, manufacturers of medical devices or medical equipment are required by European law to have a Person Responsible for Regulatory Compliance (PRRC) at their disposal at all times.


It is the role of this PRRC to ensure all regulatory activities are appropriately undertaken at all times. This PRRC however, does not need to be the person responsible for actively performing the required regulatory activities.

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Useful Information & FAQ's on Article 15

PRRC For Small Manufacturers



For micro or small manufacturers (less than 50 employees and less than €10m turnover) Cranage Veritas can provide the necessary service to act as your PRRC.


Our experience working alongside clients in the medical electrical equipment industry navigating medical device regulations and ensuring quality management systems are upheld, gives our engineers and regulatory specialists the appropriate authority to act as a PRRC on behalf of your company.


Our expert engineers and regulatory specialists have held positions working in the product safety testing industry for many years. Often performing complex testing procedures required for medical devices and electrical/electronic devices, in line with international product safety standards. So you can be assured, you are in safe hands with Cranage Veritas.


If you require this service, or wish to discuss the MDR (EU) 2017/745 with an expert advisor, get in touch with us today.


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Cranage Veritas



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Cranage Veritas Limited
Suite 232 Airport House
Shannon Free Zone
Shannon
County Clare
Ireland
V14N578