of the medical device regulations
Medical Devices
The changing tide
Peter Rose
MANAGING DIRECTOR EUROPE , MAETRICS
of the medical device regulations
Change is coming to the Medical Device Regulations and like King Canute who could not stop the tide , whether you like it or not , big changes are going to happen . Some changes are positive , some are more controversial . If you ’ re not already prepared , then now is the time to do your homework and get ready and buckle up , as it ’ s going to be a bumpy ride for the uninitiated
Currently in Europe , medical device manufacturers are subject to the Medical Device Directive 93 / 42 / EEC ( MDD ). The process of updating the rules became highly politicised following the PIP breast implant fraud , Metal on Metal ( MoM ) hip implant vigilance failures and issues with pelvic floor meshes . In addition to these issues , various inconsistencies across Notified Bodies ( NBs ) were highlighted . The original intention was to modernise the legislation , improve patient safety and assist innovation and trade across the EU . The process evolved into what is now called the Medical Device Regulation ( MDR ).
How deeply manufacturers are affected will depend to a great extent on what products they are manufacturing or developing . It will also depend on how well informed they are , what level of regulatory expertise they have and how agile they are when it comes to change .
The timeline for these changes is a constantly moving target ; however the movement is slowing down with latest expectations that the MDR is to be published in Q4 / 2016 . There will be no ‘ grandfathering ’ of legacy products , every device must be subject to a full reassessment of the Technical File .
In addition to changes of the MDD , there are further regulatory changes happening that will affect manufacturers . Own Brand Labelling ( OBL ) requirements have never been a specifically recognised concept in the MDD , however it has been tolerated
The process of updating the regulations became highly politicised following the PIP breast implant fraud
The main ethos driving the changes to the regulations is to ensure medical devices are of a high standard and continually safe
through guidance . That guidance has now been tightened and will require : an on-site Quality Management System audit ; Documented Technical File ; Unannounced inspection with the Original Equipment Manufacturer ( OEM ) and that the OEM must declare they are the original manufacturer , a process that will effectively outlaw any chains of OBL .
Other regulatory changes include , Authorised Representatives ( AR ) having to take on product liability and the introduction of a proposal for all manufacturers to have compulsory liability insurance . The Medicines & Healthcare Products Regulatory Agency is also contributing to the list of changes that will affect manufacturers ; they are due to release a consultation document on the imposition of surveillance fees on medical device manufacturers selling to the UK . Not to mention that the UK government is introducing an Apprenticeship levy which will affect all employers – the levy will be 0.5 per cent of annual payroll where it is in excess of £ 3 million . In addition to the REACH regulations , there is also a list of Substances of Very High Concern ( SVHC ) of which 168 substances can only be used in medical devices at a maximum of 0.1 per cent w / w at the component level ( not 0.1 per cent w / w of the whole device ).
The implementation process is running at least two years behind the original intention and there are still aspects that
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