The EU’s medical device regulations 2017/745 and 2017/746 require that each device placed on the market must be accompanied by a unique device identification (UDI) which shall be used for identification and traceability purposes, this requirement applies to all devices apart from custom-made and investigational devices. UDI Structure The product specific UDI is comprised of
To give you a flavour of some of the worries that current QCS clients have: Brexit The new Medical Device Regulations LRQA and UL abandoning their notified body status Only 2 Notified Bodies currently qualified for the full continent of Europe for MDR 12- month Lead times for Technical File Examinations EUDAMED not completed A
Theresa May’s recent heralding of Artificial Intelligence in Healthcare as a potential focus for UK research and development provides an opportunity to define our regulatory expectations for this tech. “The development of smart technologies to analyse great quantities of data quickly and with a higher degree of accuracy than is possible by human beings opens
The main point of any management system is continuous improvement. Practically this means that we identify issues that are causing significant business cost, loss or risk and then we set about solving the issue by identifying the root cause, and then putting in place a corrective action. Root Cause Analysis If you are running a
One great debate that always comes around when auditing Regulatory Affairs as part of your ISO 13485 system relates to change notifications to notified bodies. When exactly do you report a change i.e. when is a change a significant change? Help is at hand in the EU Association of Notified Bodies give guidance on this
Although this is probably not the most exciting audit to do, it is worth performing an audit across your business from time to time to assess how documentation is controlled. A question of risk… It is important when planning your audit to look at the overall risk to your business posed by documentation control. The
ISO 14971:2009 was published last year by BSI with three additional annexes to show links to the applicable device directive. Read a summary of the new ISO 14971 annex for the MDD (Medical Device Directive) here. ISO 14971 Update So is it worth paying out for the new standard? – I will leave you to judge
When a Certification Body issues a nonconformity (or nc) during an audit, there is strict guidance they must follow to close out the nonconformity. In this article, we provide a comprehensive 10-point checklist to help you achieve complete nc closure during your next audit. Correction: What the auditor is looking for… Identification and Containment: The