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).
KEMA has been officially designated to review the compliance of products to the essential requirements of the MDD for access to the EU market. KEMA is also accredited to grant access to markets in other countries. Moreover, you can call on KEMA for certification of your Quality Management System according to
ISO 13485. On March 21, 2010 Directive 2007/70/EC will be in place and mandatory for the medical device manufacturers.
KEMA: One-stop shopping- KEMA has a global presence
- All your testing and certificates at one institute: In addition to the Medical Device Directive, you can also call on KEMA for AIMDD, IVDD, IEC 601 tests, 510(k) reviews , and ISO 13485
- Specialists with extensive experience in the medical industry assess your products
- KEMA keeps the time to market as short as possible thanks to a special program
- You have one, permanent contact throughout the entire process
- KEMA participates in all the MRAs (i.e. US, JAPAN, Taiwan, Australia)
- KEMA is an expert in drug/device combinations and products with animal material
- Dissatisfied with the service you receive from your present Notified Body? KEMA has experience in assuming certificates.
More information? Contact us.