EU - Medical Device Regulation

Product Brand: PG Drives Technology

The European Union’s Medical Device Regulation’s Date of Application is May 26th 2021, when it will replace the Medical Device Directive (93/42/EEC).

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Americas

LA, CA
T: +1.714.982.1860
cwig.us@curtisswright.com

São Carlos, Brazil
T: +55.16.2107.8745
cwig.br@curtisswright.com

Europe

Christchurch, UK
T: +44.1202.034000
cwig.uk@curtisswright.com

Asia

Shanghai, China
(Industrial Controllers)
T: +86.21.3331.0670
cwig.cn@curtisswright.com

Taipei, Taiwan
(Medical Mobility)
T: +886.2.2778.1900
cwig.tw@curtisswright.com

Singapore
T: +65.6241.2508
cwig.sg@curtisswright.com

Rest of World

Christchurch, UK
T:+44.1202.034000
cwig.uk@curtisswright.com

DEFINITION OF ABBREVIATIONS

  • DoA:                 Date of Application
  • DoC:                 Declaration of Conformity
  • EU:                   European Union
  • MD:                  Manufacturer’s Declaration
  • MDR:                Medical Device Regulation
  • OJEU:              Official Journal of the European Union

SUPPORT FROM CURTISS-WRIGHT

As suppliers of components to Medical Devices, Curtiss-Wright are well-positioned to support our OEM customers and their supply chains in meeting the requirements of the MDR.

The basis of this support is to supply a Manufacturer’s Declaration for each product type, which can be included in the overall documentation for the Medical Device to which the control system is fitted. This approach is necessary as, under the definition provided in the MDR, a control system is a part with no function of its own meaning it is a component of a Medical Device. Therefore, a Declaration of Conformity or CE Mark is not appropriate until the component is incorporated into the final product, i.e. a mobility vehicle.

As such, MDs are issued to aid the installation of the component (control system) into the finished product (mobility vehicle).

Curtiss-Wright can supply MDs for: S-DrivenewVSI(n)VR2 and R-net.

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TÜV CERTIFICATION                                    

Although TÜV certification is not a requirement of the MDR, it does give assurances a product is designed and manufactured to the highest standards.

TÜV certificates are available for: S-DrivenewVSI(n)VR2 and R-net         

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NOTE ON NDR ANNEX 1

As of the DoA of the MDR, it will not state any mobility-vehicle-specific harmonized (cited in the OJEU) standards. To mitigate this, all CW control systems will be designed to comply with the latest versions of:

  • EN 10993-1
  • EN 12182
  • EN 12184
  • EN 14971
  • EN 62304

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