The approaching EU Medical Device Regulation – which will become applicable on 26 May 2020 – puts great emphasis on the assessment of product safety and performance by placing stricter requirements on clinical evaluation, post-market clinical follow-up and traceability of devices. Thus, the manufacturers worldwide need to perform some crucial adjustments in order to become compliant with the new law.
As the MDR will bring some significant changes within the entire medical devices industry, will the changes affect the fundamental principles of conducting conformity assessments? Generally speaking –not so much as mainly the numbers of Annexes have been changed (Annexes II to VIII of the MDD will be replaced by Annexes IX to XI and XIII of the new MDR).
However, one of the novelties introduced within the MDR which concerns Conformity Assessment is the added requirement for the Notified Bodies to consult with Health Authorities and EU expert panels, which is expected to prolong quite remarkably conformity assessments route for Class III devices.
Other than this, the approach of conducting the conformity assessment route for all MD classes remains essentially similar to Directive 93/42/EEC.
For Class I devices, the manufacturer prepares the Declaration of Conformity (described in the new Article 19) in accordance to Annex IV after having fulfilled the general obligations listed in the new Article 10 of the MDR. The involvement of a Notified Body for Class I devices is limited to devices provided in sterile condition, conformit to the metrological requirements or aspects related to the reuse of the device.
Regarding Class IIa and IIb devices, the MDR provides several options for implementing the conformity assessment: either assessing the Technical Documentation of a representative sample of the devices (Annex XI, Part A – “Production Quality Assurance”), or carrying out tests to confirm the conformity of the devices (Annex XI, Part B – “Product Verification”). However, there is a difference. When assessing the Technical Documentation for Class IIa, a Notified Body assesses at least one representative device per category while for class llb devices per generic device group.
For Class III devices, conformity assessment will be based on quality management system assurance and assessment of the technical documentation (Annex IX of MDR). For this high class of devices, the technical documentation must be assessed per each file – no sampling allowed.
Lastly, for custom-made devices, the MDR dedicates the whole Annex XIII – “Procedure for custom made devices” which displays the requirements to draw up a statement about the device and keep the records. As for Class III custom-made devices, a quality system assessment by a Notified Body has to be performed: either the “Quality Management System Assessment” of the new Annex IX, Chapter 1 or the “Production Quality Assurance” of the new Annex XI, Part A.