Failure to Comply: Risks of Non-Compliance

Without a doubt, non-compliant products are entering the market  everyday - whether intentionally by the manufacturer or   misunderstanding of the Medical Device legislation or through a naivety  of the meaning of affixing the CE Marking.

The main risks of non-compliance include, but are not limited to:

  • Revocation of the CE Marking
  • Fines
  • Warehousing/holding fees
  • Mandated recalls/withdrawals
  • Banning of marketing on the EU Market

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With the Medical Device Regulation transition well underway, be  sure to learn about the upgraded requirements in order to comply by the May 2020 deadline.

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