Medical device manufacturers have three years from 25 May 2017 to transition to the MDR with an obligation to update both technical documentation and processes in line with the new requirements. Certificates issued under the MDD during the MDR transition period remain valid for a maximum of four years from the date of issue.
The MDR differs significantly from the outgoing Medical Device Directive (MDD) (93/42/EEC), which was first introduced in 1993. Aside from being three times larger, further key differences include:
- The inclusion of active implantable devices: an expansion of scope that includes products with an aesthetic or non-medical purpose, but which are similar to medical devices in terms of risk profile
- New classification rules for devices using nanomaterials and orally-administered products with a requirement for conformity assessment.
The previous EU regulatory framework for Medical Devices consisted of the MDD and Active Implantable Medical Devices Directive (AIMD) 90/385/EEC. The revision combines the two directives and was introduced as a Regulation instead of a Directive.
A Regulation was chosen as it imposes clear and detailed rules for member states, and ensures legal requirements are implemented consistently throughout the EEA.
Introducing the revision as a Regulation allowed the European Commission to alter the requirements with the goal of achieving three core objectives:
- Give patients, consumers and healthcare professionals confidence in the devices they might use every day
- Allow the industry to bring safe, effective and innovative products to market quickly and efficiently
- Increase the ability of forward-thinking companies to attract investors, estimate costs and anticipate procedures
Scope of regulated MD products
The MDR clarifies and expands the scope of regulated medical devices to include aesthetic devices with a non-medical purpose that are similar to medical devices in terms of risk profile, specific rules for devices that incorporate nanomaterials, devices intended to be ingested or inhaled, and medical software.
There is also an expansion of Rule 17 to include devices manufactured using non-viable tissues or cells of human origin.
Pre-market scrutiny procedure
To improve the overall quality of Notified Bodies and their review of certain categories of high-risk medical devices, the European Commission proposed a ‘scrutiny’ procedure of the Notified Body’s preliminary assessment report for implantable medical devices classified as class III, prior to the granting of certification.
This mechanism allows the newly-formed committee of Member State authorities, the Medical Devices Co-ordination Group (MDCG), to monitor applications handled by Notified Bodies and flag those which, prior to the Notified Body issuing a decision, they would like to review.
CE marking would subsequently depend upon both the manufacturer and the Notified Body addressing issues identified by the MDCG.
Person responsible for regulatory compliance
Manufacturers will be required to have available, within their organisation, at least one person responsible for regulatory compliance who possesses expert knowledge in the field of medical devices.
Identification and traceability
As per the IVD Regulation, Medical Device manufacturers must fit their devices with a Unique Device Identification (UDI). The MDR gives full details of the information that must be accessible via the UDI.
There is a further obligation for high-risk device manufacturers to provide a publicly-available safety and performance summary, including the key elements of supporting clinical data.
Vigilance and market surveillance
The EU Commission proposes to set up and manage an electronic system to collate and process reports by manufacturers on serious incidents, field safety corrective actions and field safety notices with periodic summary reports.
The position of Notified Bodies in relation to manufacturers will be significantly strengthened as they gain a right and duty to carry out unannounced factory inspections alongside physical or laboratory tests on devices.
The proposal also requires rotation of the Notified Body’s personnel involved in the assessment of MDs at appropriate intervals to strike a reasonable balance between the knowledge and experience required to carry out thorough assessments.
Timescale for introduction and transition
Medical device manufacturers have three years from 25 May 2017 to transition to the MDR. Manufacturers can continue placing devices on the market with valid MDD certificates provided that there are no significant changes to the device until May 2024.
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