The new European Union (EU) Medical Device Regulation (MDR) will replace the existing Medical Device Directive (MDD) 93/42/EEC and Active Implantable Medical Devices (AIMD) Directive 90/385/EEC when it is published, currently estimated for Q4 2016.
As with the upcoming In-Vitro Diagnostic Device Regulation (IVDR), the proposed Medical Device Regulation (MDR) is also approaching the final stages of development before becoming law as a Regulation.
New EU MDR Requirements and Key Changes
The MDR differs significantly from the outgoing MD Directive (93/42/EEC) that was first introduced in 1993 and contains a series of new requirements and key changes, including:
- Wider scope of regulated devices – the Regulation clarifies and expands the scope of regulated MD devices to include: aesthetic devices with a nonmedical purpose but which are similar to medical devices in terms of function and risk profile, specific rules for devices incorporating nanomaterials and devices intended to be ingested or inhaled and medical software. There is also an expansion of rule 17 to include devices manufactured utilizing non-viable tissues or cells of human origin.
- Inclusion of active implantable devices – expansion of scope to include products with an aesthetic or nonmedical purpose but which are similar to medical devices in terms of function and risk profile.
- New classification rules for devices utilizing nanomaterials orally-administered products and requirements for conformity assessment.
- More stringent clinical evidence and documentation, including an obligation for high-risk device manufacturers to make a summary of safety and performance publicly available, with key elements of the supporting clinical data.
- Increased focus on identification and traceability – as per the IVD Regulation that has been proposed, Medical Device manufacturers must fit their devices with a Unique Device Identification (UDI). The proposed Regulation gives full details of the information that has to be accessed through the UDI.
- Increased Notified Body authority, involvement and unannounced factory audits/inspections – NBs will have a right and duty to carry out unannounced factory inspections and to conduct 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 as well as a ‘scrutiny’ procedure of the notified body’s preliminary assessment report for implantable medical devices classified as class III by Member State Authorities’ Committee, prior to the granting of the certification.
- More rigorous 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, field safety notices and periodic summary reports.
- At least one person responsible for regulatory compliance who possesses expert knowledge in the field of medical devices.
New EU Medical Device Directive – Guidance and Support
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