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Medical Device Directive

Medical Device TestingThe Medical Device Directive 93/42/EEC (MDD), at first glance, is filled with confusing rules, device classifications, and conformity requirements. In simple terms, the aim of the MDD is:

  • To define the essential requirements that medical devices must meet before being placed on the market
  • To establish conformity assessment procedures based on device classifications
  • To create tracking and reporting mechanisms available to national authorities to ensure and protect public health


In order to market your medical device within the member states of the European Union, your product must comply with the essential requirements of the MDD. Compliance with harmonized standards (such as EN 60601-1-2:2001 for EMC, and EN 60601-1 for electrical safety) can provide assumption of conformity to specific requirements.

As part of the MDD’s essential requirements (Annex I), you must also provide the following:

  • Technical Documentation (Technical File) - Technical documentation should contain full construction details and validation/verification data for your medical device. This will prove that you comply with the essential requirements of the MDD.
  • Risk Assessment - Your product’s risk assessment must include a construction evaluation, materials used, bio-compatibility analysis, infection and cross-infection risks, and potential risks during use. The resulting documentation becomes part of the Technical File.
  • Quality System – Your organization must meet the quality system requirements of the MDD. Conformity to ISO 13485, which is a harmonized standard in the EU, is a way to demonstrate conformity to the quality system requirements of the MDD for those annexes applicable.
     


Depending on your product classification, you may also need Notified Body approval. Within the Intertek Group, there are three European Union based Notified Bodies to the MDD:

  • Intertek Testing & Certification, UK, N/B No: 0359
  • Intertek Semko, Sweden, N/B No: 0413
  • Intertek ACSL, UK, N/B No: 0473


Once you have met all applicable requirements, it is your responsibility to show conformity with the Medical Device Directive by affixing the CE Mark to your device. CE marking for medical devices

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