Medical device manufacturers have to comply with stringent requirements to access the European market.
The current EU regulatory framework for medical devices consists of the three Council Directives;
It is proposed to combine the AIMD and MDD (and amendments) into one new Regulation. The IVD will be revised separately.
Purpose behind the changes:
How Smithers can help
- Product and device testing: mechanical, physical, chemical and transit testing.
- Design control support
- Long term performance data generation (e.g. creep and fatigue)
- Risk analysis and preparation of design and process FMEAs
- Quality management systems implementation and auditing
About the Regulations
The medical device directive 93/42/EEC will be recast as a regulation and will impose clear and detailed rules that ensure that legal requirements are implemented at the same time throughout the European Union. Casting the document as a regulation will also help avoid divergent transposition by Member States, as has been seen with the IVD, thus simplifying matters.The current EU regulatory framework for medical devices consists of the three Council Directives;
- 93/42/EEC, concerning medical devices (the Medical Device Directive, MDD)
- 90/385/EEC, relating to Active Implantable Medical Devices (AIMD)
- 98/79/EC, on In Vitro Diagnostic Devices (IVD)
It is proposed to combine the AIMD and MDD (and amendments) into one new Regulation. The IVD will be revised separately.
Purpose behind the changes:
- Giving patients, consumers and healthcare professionals confidence in the devices they might use each day.
- Allowing industry to bring compliant, effective and innovative products to market in a quick and efficient manner.
- To increase the availability of innovative products, to attract investors, to help define/anticipate procedures and estimate costs.
- Improved coordination and cooperation between Member States.
- More effective governance structure of Member State experts through the Medical Device Co-ordination Group (MDCG).
- More traceability with unique device identification (UDI).
- Alignment with the new legislative framework.
- More rigorous designation and audit of notified bodies.
- Increased regulation for reprocessing of single use devices.
- Clearer requirements for clinical evidence.
- More information available on the quality and integrity of devices in the market.
- Central reporting of serious incidents and field corrective actions.
- Manufacturers are to provide at least one qualified person who possesses expert knowledge in the field of medical devices.
- Extension to invasive and implantable devices which have no medical purpose.
- Obligations to authorised representatives, importers and distributors.
- Unannounced inspections by notified bodies to medical device manufacturers and their critical subcontractors.
- Greater responsibility for Contract Manufacturing Organisations (CMOs) for final product quality.
- Clearer requirements for Clinical Evidence.
- Manufacturers of medical devices are to provide a ‘qualified person’ who possesses expert knowledge.
- CMOs must have access to technical documentation and have a suitable management system.
- Ensuring EU harmonized standards are used, such as the Quality System standard ISO13485, Risk Management Standard ISO14971, Biological Evaluation ISO 10993 and Biocompatibility Evaluation of Breathing Gas Pathways ISO 18562.
- The regulation goes upstream in the supply chain. It clearly involves Contract Manufacturing Organisations (CMOs) in the final product quality. This defines critical sub-contractors, which design, manufacture or perform services for a part of the medical device, and critical suppliers, which supply essential components as raw materials and moulded parts. Those organisations must keep under the control of their order giver and his Nominated Body, which must perform planned and unannounced audit in their premises too.
- Example: If a medical device manufacturer purchases plastic component parts from a molder and assembles them into a medical device at the manufacturer's premises, the manufacturer is obligated that their notified body audits the molder to the same quality system standards that they comply with.
