Notified Bodies – What Are The Implications for the Medical Devices Sector?
The implications of Brexit will, possibly, be felt most in the area of Notified Bodies. The UK’s exit from the European Union means that UK based Notified Bodies will no longer be permitted to provide conformity assessment services and issue CE Certificates of Conformity to manufacturers. There is no doubt that the upheaval caused by this will have an impact on the sector. Anecdotal evidence already suggests that Notified Bodies within the remaining EU27 members states are experiencing increased demands on their services and they are unable to meet demand in as quick a time as customers would like.
At present UK Notified Bodies are operating on the same basis as other Notified Bodies within the EU. This, however, will change in March 2019 when the UK formally leaves the EU and enters into (or not) a transitional period while a number of customs and trade deals are negotiated. At that time UK Notified Bodies will no longer be able to provide any of the services listed above and they will be removed from the European Commission’s Notified Bodies information system (known as NANDO).
Companies with a UK issued CE Certificate will have until March 2019 to apply for a new CE Certificate in an EU 27 country or consider arranging a transfer of technical files and the UK issued CE Certificate to an EU Notified Body. The new appointed EU based Notified Body will then take responsibility for that certificate. Such a move will entail developing an arrangement between the manufacturer, the UK Notified Body and the newly appointed EU Notified Body.
Finally, it is worth noting that in a time of transition to MDR and IVDR that many NB’s are experiencing capacity issues because they are in the midst of a re-designation to comply with MDR and IVDR.
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