Medical Devices Directive - New Regulation

As with the upcoming In-Vitro Diagnostic (IVD) Device Regulation, the proposed Medical Device Regulation (MDR) is also approaching the final stages of development before becoming law as a Regulation. 

The MDR differs significantly from the outgoing MD Directive (93/42/EEC) that was first introduced in 1993. Aside from being three times larger, the key differences include:

  • 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 utilising nanomaterials orally-administered products and requirements for conformity assessment.

Introduction to the MD Regulation 

The current EU regulatory framework for Medical Devices consists of the MD Directive (MDD) 93/42/EEC and Active Implantable (AIMD) Medical Devices Directive 90/385/EEC. 

The proposed revision will combine the two directives (MDD & AIMD) and shall be introduced as a Regulation instead of a Directive. A Regulation was chosen as it imposes clear and detailed rules which do not give room for divergent transposition by member states, and ensures legal requirements are implemented at the same time throughout the Union. 

New requirements 

With the revision being introduced as a Regulation, the European Commission has three key objectives:

  • "to give patients, consumers and healthcare professionals confidence in the devices they might use every day" 
  • "to allow industry to bring safe, effective and innovative products to market quickly and efficiently"
  • "to increase the availability of innovative companies to attract investors, estimate costs and anticipate procedures". 

Scope of Regulated MD Products

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 utilising non-viable tissues or cells of human origin. 

Pre-market Scrutiny Procedure 

Aimed at improving the overall quality of notified bodies and their review of certain categories of high-risk class 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 by Member State Authorities’ Committee, prior to the granting of the certification. 

This mechanism foresees that the newly formed committee of Member State Authorities, the Medical Devices Coordination Group (MDCG), monitors applications being handled by notified bodies and flags those for which, prior to the notified body issuing its decision, they would like to check and comment upon the notified body’s assessment and, in turn, the submission dossier of the manufacturer. The CE marking would be dependent upon both the manufacturer and the notified body addressing any 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 that has been proposed, Medical (MDD) Device manufacturers must fi t 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. 

There is also 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. 

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. 

Notified Bodies 

The position of notified bodies in relation to manufacturers will be significantly strengthened. They 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 to strike a reasonable balance between the knowledge and experience required to carry out thorough assessments. 

Timetable for introduction and transition 

The new Regulation will become applicable three years after its entry into force. The expected publication date is early 2016.

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