Biggest challenge when seeking EU MDR compliance

The biggest challenge is to prepare all the necessary documentation that MDR requires. Now, it depends on whether you already have a certified product according to MDD or it is a completely new product that has never been certified before. If you already have a medical device certified according to the MDD (so-called legacy devices), then the situation is somewhat easier because you have most of the documentation already prepared. 

For more information what is difference between MDD and MDR see the following links:

• Infographic: EU MDR vs. MDD – What has changed? https://advisera.com/13485academy/blog/2020/11/24/infographic-eu-mdr-vs-mdd-what-has-changed/
• 8-step transition process from MDD to MDR https://info.advisera.com/13485academy/free-download/8-step-transition-process-from-mdd-to-mdr/

There is some more guidance from the MDCG group regarding legacy devices:

• MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2020_6_guidance_sufficient_clinical_evidence_en.pdf
• MDCG 2019-5 Registration of legacy devices in EUDAMED  https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2019_5_legacy_devices_registration_eudamed_en.pdf

Documentation that needs to be covered by the MDR is Technical documentation for the medical device, but also the quality management system that has some more requirements than ISO 13485. Requirements for technical documentation you can find in Annex 2 and Annex 3 and additional requirements for quality management system are covered in Article 10 – General obligation of the manufacturer, point 9.

For more information, see:

• EU MDR Article 10 – General obligations of the manufacturers https://advisera.com/13485academy/mdr/general-obligations-of-manufacturers/
• EU MDR Annex 2 – technical documentation https://advisera.com/13485academy/mdr/technical-documentation/
• EU MDR Annex 3 – Technical documentation for post-market surveillance https://advisera.com/13485academy/mdr/technical-documentation-on-post-market-surveillance/

To help you in the preparation of the technical documentation, please read the following article:

• What are the EU MDR technical documentation structure and requirements you can find? https://advisera.com/13485academy/blog/2021/04/06/what-are-the-eu-mdr-technical-documentation-structure-and-requirements/