Overview of the role of Key Stakeholders in the Medical Device Regulations
The new MDR will apply across EU Member States from May 2020, under this regulation there are defined obligations which lie with the major stakeholders in the device lifecycle. These obligations need to be fulfilled to ensure compliance with the regulation when placing the device on the market.
Manufacturer
- Dependent on classification of the device, will get a CE certificate from the Notified Body or self-certify the device.
- Affix CE mark.
- Responsible for placing CE marked product on the market.
- Responsible for registering products on the EUDAMED database
- Retain technical documentation, CE certificates and Declaration of Conformities
- Implement and keep up to date the post market surveillance process.
- Have a system for recording and reporting of incidents and field safety corrective actions
- Have a vigilance reporting process in place.
- Take corrective action for the device and inform the required parties i.e. competent authority
- Legally liable for the device
Importer
Must be established within the European Union
- Register on the Eudamed database.
- Ensures an authorised representative has been designated.
- Will only place product conforming with the regulation on the market
- Ensure storage/transport conditions comply with the specification determined by the manufacturer
- Keep a register of complaints, non-conforming devices, recalls.
- Assists with corrective actions
Distributor
- Distribute conforming product on the market.
- Ensure storage/transport conditions comply with the specification determined by the manufacturer
- Keep a register of complaints, non-conforming devices, recalls.
- Assists with corrective actions
Authorised Representative (AR)
Must be established within the European Union and has specific responsibilities on behalf of the manufacturer.
- Verify DoC and technical documentation.
- Must retain a copy of technical documentation, CE certificates and Declaration of Conformities
- Register on the Eudamed database
- Register the devices with the competent authority.
- Register on the Eudamed database.
- When requested must provide documentation/information to authorities.
- When requested by the authority must submit the request for samples etc. to the manufacturer.
- Assist with corrective actions
- Is legally liable for defective devices on the market
Person Responsible for regulatory compliance (PRRC) i.e. Safety Officer
- Verifies technical documentation and Declaration of Conformity and ensures it’s kept up to date.
- Is responsible for reporting obligations to authorities.
- Ensure PMS is performed
Each stakeholder must be familiar and aware of their obligations as defined in the medical device regulation. KD&A can provide your organisation with guidance on the road to compliance with the MDR and placing your product on the market.