Useful Information for Medical Device Regulation (EU) Article 15

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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