Medical Device Directive (93/42/EEC)

Access to the European market

You manufacture medical devices, which are only allowed on the European market if they comply with the Medical Device Directive (93/42/EEC). DEKRA has been officially designated to review the compliance of products to the essential requirements of the MDD for access to the EU market.

DEKRA is also accredited to grant access to markets in other countries. Moreover, you can call on DEKRA for certification of your Quality Management System according to ISO 13485. Since 2010 Directive 2007/70/EC is in place and mandatory for the medical device manufacturers.

DEKRA is your full service provider:

  • DEKRA has a global presence
  • All your testing and certificates at one institute: In addition to the Medical Device Directive, you can also call on DEKRA for AIMDD, IVDD, IEC 60601* tests and ISO 13485
  • Specialists with extensive experience in the medical industry assess your products 
  • You have one, permanent contact throughout the entire process
  • DEKRA participates in all the MRAs (i.e. US, JAPAN, Taiwan, Australia)
  • DEKRA is an expert in drug/device combinations and products with animal material
  • Dissatisfied with the service you receive from your present Notified Body? DEKRA has experience in assuming certificates.