Over the past years, the I3CGLOBAL team has guided many manufacturers in achieving CE marking approval for medical devices, under MDR. A medical device can only be placed on the EU market if the device is CE Certified or CE Logo affixed
This means that the CE Marking for medical devices should have complied with MDR requirements, including testing, inspection, and GSPR, so it ensures safety and performance. In practice, all manufacturers must carry out the conformity assessment as described in MDR and draw up a Declaration of Conformity (DOC) which must be included in the technical file.
The types of conformity assessment depend on your medical device’s classification and device’s intended use and sterility nature. Annex IX for assessments based on a quality management system and technical documentation; Annex X for type examination assessments; and Annex XI for product conformity testing assessments.
CE approval for Class I Medical Devices
For Class I devices (except for measuring, sterile, and reusable), the manufacturer can opt for self-certification. To declare conformity of the device, the manufacturer issues the EU Declaration of Conformity according to Article 19 of the MDR, after fulfilling the general obligations listed in Article 10. The Technical Documentation should be maintained as per Annexes II and III.
CE approval for Class IIa Devices
Conformity assessment for Class IIa devices can be carried out under Annex IX, which requires a full QMS and an audit by the Notified Bodies, along with their evaluation of the Technical Documentation. In the case of Class IIa devices, a Notified Body assesses at least one representative device per category, while for Class IIb devices, the assessment is conducted per generic device group.
CE approval for Class IIB Devices
For Class IIb medical devices, whether implantable or non-implantable, follow, Annex IX Chapter I for the QMS and Section 4 for the Technical Documentation, or Annex X (Assessment based on Type-Examination) and Annex XI-Part A (Production Quality Assurance), or Annex X (Assessment based on Type-Examination) and Annex XI-Part B (Product verification).
CE approval for Class III Devices
Class III devices, conformity assessment is based on quality management system assurance and assessment of the technical documentation
Annex IX and an expert panel will also be required to evaluate Class III implantable devices, or Annex X and Annex XI-Part A or Annex X and Annex XI-Part B
There are additional requirements in Annex IX devices incorporating animal or human tissues/cells, or medicinal substances
Clinical evaluation is an essential component of the technical documentation, as outlined in paragraph 3 of Article 61. This process involves a well-defined and methodologically sound procedure that includes evaluating relevant scientific literature and examining investigation results.
This process should adhere to the guidelines of MEDDEV 2.7/1 rev4 until specific guidance on Clinical Evaluations is issued by the MDCG It’s important to note that no exemptions are made based on the device’s classification, meaning that all types of medical devices are required to undergo the same process for clinical evaluation.
I3CGLOBAL’s team of regulatory experts is involved in reviewing technical documentation, analysing necessary literature, and writing the clinical evaluation report. We have supported numerous manufacturers in obtaining a CE certificate for their medical devices as per MDR 2017/745.
