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Useful Information for Medical Device Regulation (EU) Article 15



PRRC Frequently Asked Questions


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PRRC – Article 15: MDR (EU) 2017/745



The Medical Device Regulation (MDR) (EU) 2017/745 came into effect on the 25th of May 2017 and operates to replace the following directives:

  • Medical Devices Directive (92/42/EEC)
  • Active Implantable Medical Devices Directive (90/385/EEC)

As such, manufacturers of medical devices or medical equipment and systems 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.


The full responsibilities of the PRRC according to article 15 of the MDR (EU) 2017/745 are as follows:

  • To ensure the device conforms to the manufacturer’s quality management system prior to release.
  • The technical documentation and EU declaration of conformity are properly maintained.
  • The post market obligations are complied with.
  • The reporting obligations are fulfilled for serious incidents, field safety corrective actions and trend reporting.
  • In case of investigation devices, the statement referred to in section 4.1 chapter II of annex XV is issued.

A company may employ more than one PRRC and this is often the case for larger companies where the tasks would be too burdensome for an individual PRRC.

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PRRC For Small Manufacturers



For smaller companies this employment of an individual responsible for regulatory compliance may be unviable, as costs can be too much of an expense.


There is an allowance for this, if you are classed as a micro or small manufacturer (detailed as having fewer than 50 employees and annual turnover does not exceed €10m), then you may subcontract this role to an external party.


Our experience working alongside clients in the medical electrical equipment industry gives Cranage Veritas the appropriate authority to act as a PRRC on behalf of your company.


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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