The three pieces of CE Marking legislation covering Medical Devices; The Medical Devices Directive (93/42/EEC), the Active Implantable Medical Devices Directive (90/385/EEC) and the In Vitro Diagnostic Medical Devices Directive (98/79/EC) are soon to be replaced with two new Regulations.
The Medical Devices Directive and Active Implantable Medical Devices Directive are to be merged into a new Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Directive will be replaced by a new regulation (EU) 2017/746. The new regulations will come into force on 26th May 2020 (2017/745) and 26th May 2022 (2017/746); the UK Government has committed to implementing the new Regulations regardless of the outcome of Brexit.
The main changes from the old Directives focus around Technical Documentation with a greater emphasis put on documenting Post Market Surveillance and an increased robustness in the validity of clinical data required.
Notified Bodies will lose their notification under the old Directives on 26th May 2020 (93/42/EEC & 90/385/EEC) and 26th May 2022 (98/79/EC) by which time they should apply for notification under the new Regulations. However Notified Body certificates issued after 25th May 2017 against the old Directives will be valid for the period indicated on the certificate or until 27th May 2024; whichever occurs sooner.
By way of derogation, Manufacturers may place devices on the market which comply with the new Regulation immediately, however as at the time of writing, only two Notified Bodies hold notification under 2017/745 and none under 2017/746, in practice, this may only apply to devices requiring no Notified Body involvement.
If you need any help or support with CE Marking under the Medical Devices Directive, then please call us on 01564 792349
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