Is your file ready for the new Medical Device Regulation?

On 26 May 2020 the transition period will end and the Medical Device Regulation (MDR) 2017/745 enters into force and the current Medical Device Directive (MDD) 93/42/EC will be repealed. This means that from 26 May 2020 the technical documentation of your medical devices must be in compliance with the MDR requirements.

How do I need to update my existing files to comply with the new MDR?
It is important to identify the so-called ”gaps” in your current documentation to ensure which changes need to be made to fulfill the requirements of the regulation.

These gaps indicate the difference between your current file and the required information of the Medical Device Regulation. Do your manual or certificate contain all the necessary information for example.

Our medical branche CE Medical can carry out a gap analysis to identify the gaps and to indicate the problem areas in your current documentation and file.

We will indicate the gaps and solutions in accordance with the MDR

With in-depth knowledge and many years’ experience in the medical device world, and fully focused on the new MDR 2017/745, we have developed custom made assessments to assess your existing files, determine the gaps and indicate how the gaps can be filled to ensure compliance with the MDR.

CE Medical closely analyses your existing data and through proven methods indicate what must be modified to ensure that your files are in conformity.

  What we review:

  • Design file with regard to CE marking
  • Technical file complying to CE marking
  • Evaluation of device classification
  • Review the risk management file
  • Evaluation of clinical reports
  • Procedures for post-marketing plans
  • Labeling requirements
  • Authorized representation documentation, contracts, etc.

 

Our custom made report will indicate the gaps that must be filled to reach the conformity of your documentation.

We work closely with your company to ensure the documentation is ready for submission to the notified body.

Be aware that there is a limited time frame to bring your files in order.

Medical Devices in the case of Brexit
When the UK is no longer is part of the EU the roles of the economic operators (manufacturer, distributor, importer, authorized representative, etc.) will change.

The far most important change with regard to authorized representatives is that UK based authorized representative will not be recognized in the EU.

Read more over here:

– The UKCA, the regulatory framework of the UK in case of Brexit

– Medical devices in the event of a no deal Brexit: What is next?

– How to Draft Instructions for Use for CE Marking of Medical Devices

– Which countries and areas accept the CE Mark?

This means that when your company has an authorized representative based in the UK, a new authorized representative must be appointed and situated in the EU.

Certification Experts offers authorized representative services to medical device manufacturers and all other fields of the industry pertaining to EU product legislation.

  • Our experts are ready to help you out

Our expertise varies from practical and theoretical solutions in Product Safety, Engineering, Quality Assurance, Technical Documentation, and the use of test facilities. For more information regarding CE Marking, check it out here.

  • Our experts are ready to help you out

Our expertise varies from practical and theoretical solutions in Product Safety, Engineering, Quality Assurance, Technical Documentation, and the use of test facilities. For more information regarding CE Marking, check it out here.

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