Another EU Notified Body leaves the ‘pond’
There seems to be a rapidly dwindling number of EU Notified Bodies (NBs) so that what was once quite a crowded pond is now looking more like a sea with very little fish in it! With fewer NBs there is less choice and less expertise available. In turn the timelines for audits, assessments and registrations will significantly increase because of lack of NBs, lack of resource and lack of knowledge.
Lloyd’s Register in the UK has confirmed withdrawal of NB services for the Medical Devices Directive 93/42/EE) (MDD) and In-Vitro Diagnostic Devices Directive (98/79/EC) (IVDD). It has gone a step further, however, by announcing that they have withdrawn their Dutch NB designation application for Medical Devices Regulation (MDR) and In-Vitro Diagnostic Devices Regulation (IVDR).
There is a small piece of ‘silver lining’ to this cloud in that Lloyd’s Register will continue to provide ISO 13485, Medical Device Single Audit Program (MDSAP) third party certification and medical device training in both the UK and rest-of-world.
If your Notified Body is Lloyd’s Register then you need to act and fast. They say that they are “working closing with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to help customers which hold certification for these Directives with Lloyd’s Register transfer to an alternative service provider”.
If you are with Lloyd’s, you need to seriously consider your options now and choose a Notified Body who can continue to support you after the new MDR and IVDR have come into full force. This is particularly relevant when we are now faced with the stark reality that there is likely to be only 30 or so NBs left in Europe who will successfully gain designation under these new regulations.
If you need help in selecting an alternative NB, please don't hesitate to contact us.