The European Directives on medical devices have been replaced by a Medical Device Regulation (MDR), which came in to effect April 2017.
In preparation for the new MDR a medical device company requested SeerPharma to map out the differences between the old Directive and new Regulation in the areas of Post Market Surveillance, so that their current systems could be assessed for any gaps.
SeerPharma assisted the client by performing:
- A review of the current text of the MDR against the current Directives in the area of
Post Market Surveillance - Preparation of a table detailing the differences in the area of Post Market Surveillance
that may impact the client. - Assessment of the client’s current procedures and practices against the new MDR and
prepared a report identifying gaps.
The work focused on the impact of the changes to the existing Quality Systems and procedures.
Contact us if you’re a Medical Device / IVD company that needs assistance with navigating the
new European Medical Device Regulation (MDR).
This post comes from our July 2017 Journal. You may also be interested in:
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- Medical Device Company Engages SeerPharma for ISO 13485 QMS
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- Effective Corrective and Preventive Action (CAPA) for Medical Devices
