Medical Device Regulation (MDR)
Smither testing provides comprehensive services to the pharmaceutical, biopharmaceutical and medical device industries to support compliance with the EU Medical Device Regulations (MDR).
Medical device companies have to comply with stringent requirements to access the European market.
How we can help
Our services include:
- Restore mechanical-physical, chemical and brand testing
- Physical data registration to review and fatigue testing
- Testing of design and process FMEAs
- Quality systems implementation and auditing
Regulations
ISO 13485:2016 will be recast as a regulation and will impose clear and direct legal requirements are implemented at the same time throughout the EU. This document as a regulation will also help avoid divergent Member States, as has been seen with the IVD, thus simplifying matters.
The regulatory framework for medical devices consists of the three Council Directives:
- Active Implantable Medical Devices Directive, AIMD
- Medical Devices Implantable Medical Devices (AIMD)
- Diagnostic Devices (IVD)
Implementing directives relating to this framework.
The AIMD and MDD (and amendments) into one new Regulation. This gives:
- Gives manufacturers and healthcare professionals confidence in the devices they use.
- Enabling compliant, effective and innovative products to market in a quick manner.
- Quality of innovative products, to attract investors, to help citizens and estimate costs.
The MDR introduces the following:
- Enhanced cooperation between Member States
- Clear structure of Member State experts through the Medical Device Coordination Group (MDCG)
- Unique device identification (UDI)
- New legislative framework
- Selection and audit of notified bodies
- No repositioning of single use devices
- New clinical evidence
- Reliable on the quality and integrity of devices in the market
- Provide at least one qualified person who possesses expert knowledge of medical devices
- Clear responsibilities for actors which have no medical purpose: end-representatives, importers and distributors
Quality Systems
Obligations imposed by notified bodies to medical device manufacturers and their sub-contractors.
Requirements for Contract Manufacturing Organisations (CMOs) for final product assembly.
Clinical Evidence
Medical devices are to provide a ‘qualified person’ who possesses expert knowledge.
Access to technical documentation and have a suitable management representative.
Quality Standards
Recognised test standards are used, such as the Quality System standard Quality Management Standard ISO13485, Biological Evaluation ISO 10993, Risk Management ISO14971, and EU Directive 2001/83/EC – which ensure quality is upheld in the supply chain. It clearly involves Contract Research Organisations (CROs) in the final product quality. This defines critical sub-stages: manufacturer is perform services for a part of the medical device, which requires essential components as raw materials and moulded items must kept under the control of their order giver and his contractors and perform planned and unannounced audit in that premises.
Summary
If a medical device manufacturer purchases plastic component parts from a supplier, only a medical device at the manufacturer’s premises. We understand that their notified body audits the molder to the same quality standards they comply with.
Contact us today to see how Smither can support your medical device testing including extractables and leachables and post-market surveillance.
