LSPs are seeing an increase in the amount of requests for information on the steps required to obtain a CE marking for medical devices intended for sale in the EU. While there are variables involved depending on the specific type of device, there are similar core steps to be taken toward a CE marking.
Contents
1. General Overview
A CE marking is a medical device manufacturer’s declaration that their device complies with the requirements of all relevant European Medical Device Regulations and/or Directives, especially the new Medical Devices Regulation (2017/745/ EU) (MDR) and the In Vitro Diagnostic Medical Devices Regulation (2017/746/EU) (IVDR).
2. The Path to MDR Compliance
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Identify a person responsible for regulatory compliance (PRRC) to help manage completion and documentation.
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Determine the classification of the device, which will dictate the conformity assessment route.
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Establish a quality management system (QMS) conforming to MDR requirements.
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Assemble a technical documentation file containing information that is pertinent to the device classification.
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Appoint an authorized representative if your company does not have a business site in Europe.
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Have the QMS and technical documentation audited by an EU-designated notified body.
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Create a declaration of conformity.
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Affix a CE mark to the device and its packaging.
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Register the device and its associated UDI in the EUDAMED database.
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Perform post-market surveillance, post-market clinical follow-up, and all other activities required to remain in compliance.
3. The Path to IVDR Compliance
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Identify a person responsible for regulatory compliance (PRRC) to help manage completion and documentation.
-
Determine the classification of the device, which will dictate the conformity assessment route.
-
Establish a quality management system (QMS) conforming to IVDR requirements.
-
Assemble a technical documentation file containing information that is pertinent to the device classification.
-
Appoint an authorized representative if your company does not have a business site in Europe.
-
Have the QMS and technical documentation audited by an EU-designated notified body.
-
Create a declaration of conformity.
-
Affix a CE mark to the device and its packaging.
-
Register the device and its associated UDI in the EUDAMED database.
-
Perform post-market surveillance, post-market clinical follow-up, and all other activities required to remain in compliance.
Download our whitepaper for more information on what it takes to gain the coveted CE mark for your medical devices.
