The revised European Medical Device Directive (MDD) is nearing completion as a Medical Device Regulation (MDR). After its reading vote in the European Parliament, the draft by the European Commission has now also passed the amendments stage with the European Council. The last round of trialogue negotiations over the final version of the Regulation are scheduled to start in autumn 2015, meaning that manufacturers and Notified Bodies could soon be facing extensive changes to approval procedures.
Far-reaching changes to device classifications, basic requirements, technical documentation and clinical data are already viewed as confirmed.
However, it is still unclear as to what amendments will apply to high-risk medical devices.
Additional testing stages in conformity assessment procedures involving newly created official authorities are viewed as likely. The new Regulation will also provide a Sound legal Basis for unannounced audits.
The following overview summarizes the changes to which manufacturers will need to adjust.
What may change?
What will the impact be?
Previous Declarations of Conformity and EC certificates will lose their validity.
A new conformity assessment procedure in line with the new Regulation will be required for the issue of a new Declaration of Conformity.
Definition of products without a medical purpose
These products will be declared medical devices.
For the first time, manufacturers of these products will have to perform conformity assessment procedures in line with the new Regulation.
Classification of some products
Manufacturers must review their previous classification and amend it if necessary.
Manufacturers must revise their proof of compliance with essential requirements.
Content of technical documentation
Manufacturers must revise all previous technical documentation and amend it if necessary.
Significance of clinical data and their evaluation by competent persons
Manufacturers may need to perform new clinical evaluations, recruiting competent staff or calling in external staff for the purpose.
Conformity assessment procedures for high-risk devices
Additional testing stages by newly created authorities may be necessary.
The additional testing stages by authorities may extend the time needed for conformity assessment procedures.
These audits will now be placed on a sound legal basis.
Manufacturers must continue to expect unannounced audits.
Stricter requirements will be imposed on Notified Bodies with respect to expertise, performance of audits, and audit times.
The working methods of Notified Bodies at all levels will be more effectively harmonized. Changes in conformity assessment procedures may result from stricter requirements imposed on Notified Bodies and on manufacturers.