Why does a medical appliance need to be certified?

Certification of a product according to attachment IV of guideline 93/42/EEC is necessary for medical devices (except class I products) as part of the conformity assessment procedure as soon as the manufacturer has decided to have the product certified in an attempt to monitor its manufacture. This conformity assessment procedure does not require a certified quality management system.

Who may have their products certified?

Only medical appliances which fall within the scope of the certification agency may be certified by Berlin Cert. At this point in time, this means only active medical appliances like devices used in surgery, stimulation appliances as well as most other medical appliances, excluding those active medical devices with ionizing rays. A detailed list of the scope of certification can be found in the designation statement on our webpage or simply ask us whether we can certify your product.

For whom does product certification make the most sense?

Product certification makes sense for all companies which – due to their structure – do not have, or not yet have, a certified quality management system according to DIN EN ISO 13485. This might include, for example, companies which manufacture mainly industrial products and happen to have a medical device in their program. The decision to have a product certified should always take into account the decreased flexibility of an individual approval by a designated agency on the one hand and the expense of introducing a quality management system on the other hand.

What needs to be submitted for product certification?

Products of class I m and II a:

  • Complete technical documentation according to attachment VII of directive 93/42/EEC
  • Application for certification, accompanied by a declaration that the application has not been submitted to any other designated agency
  • A signed order which includes an acknowledgement of the terms and conditions and certification regulations of Berlin Cert GmbH
  • If applicable, information on modifications in regard to products previously certified according to attachment IV

Additionally for products class I s or sterile II a products:

  • Proof that the sterilization of products conforms with the directives (e.g. according to V of directive 93/42/EEC)

Products of class II b or III:

  • Type approval test certificate according to attachment III of directive 93/42/EEC
  • Complete technical documentation according to attachment III of directive 93/42/EEC
  • Application for certification, accompanied by a declaration that the application has not been submitted to any other designated agency
  • A signed order which includes an acknowledgement of the terms and conditions and certification regulations of Berlin Cert GmbH
  • If applicable, information on modifications in regards to products previously certified according to attachment IV
Where can I find the legal background?

You can read about the legal background in attachments III and IV of directive 93/42/EEC.

Why certify through Berlin Cert?
  • Customer-oriented work and collegial atmosphere
  • Direct contact and quick replies to your inquiries
  • Competent and friendly team in a small certification agency
  • Many years of experience in product tests in the health care environment