Relevant to any organization involved in the production of medical devices.

Whether it’s pacemakers or syringes, if you want to show that the medical devices you manufacture are high quality and meet international regulations, GMP Medical Devices certification and product CE marking can help your organization.

With GMP certification and product CE marking in line with the European Medical Devices Regulation, you can guarantee the quality and reliability of your medical devices, growing trust with customers and creating opportunities for new business in the international market.

What you need to know

Good Manufacturing Practices (GMP) can be used to set out requirements connected to the production of medical devices; many countries have laws in place stating that medical device manufacturers must follow these procedures.

The EU Medical Devices Regulation (MDR), which combines two previous directives (93/42/EEC and 90/385/EEC) is an internationally implemented and recognized regulation, with more stringent controls than the two predecessors. Because the regulation is EU-wide, all medical devices are registered in a database, improving their traceability.

Getting certified with Kiwa

Medical devices can literally mean the difference between life and death for patients, so there is no room for error or low quality in the products or the processes behind their creation.

Kiwa provides GMP certification and CE marking for medical devices, with a laboratory that is accredited for the necessary tests to achieve the CE mark.

There is a transition period between the Medical Devices Directive and the Medical Devices Regulation, so if you manufacture currently approved medical devices, you have until May 2020 to meet the new requirements. For certain devices that meet special requirements, this period can be extended to May 2024. Kiwa can help you navigate the changes and transition to the regulation; contact us for more information.

USPs/benefits

  • Meet customers’ needs – with certification and CE marking, you can prove to customers that your medical devices are reliable.
  • Improve competitiveness – CE marking is a requirement in Europe; certification is the only way to enter a new markets if you want to do business in Europe.
  • Demonstrate your commitment to quality – GMP helps you focus on your impacts on people, not just the bottom line.
  • Boost your profits – by helping you improve processes and manage quality, GMP and CE marking can help boost your business.
  • Improve processes – with GMP, you can identify areas for improvement in your management processes, ensuring they are internationally accepted.
  • Increase efficiency – by reducing waste and avoiding product withdrawals, GMP helps you identify ways to cut costs and improve efficiency.
  • Identify risks and reduce impacts – GMP helps you identify and manage key business risks and helps you have a positive effect on people.
  • Meet legal requirements – the Medical Devices Directive is Europe-wide, so certification and CE marking opens an international market.