Medical Devices
The future is here
Change is coming to the MDR and medical device manufacturers can ’ t afford to not be prepared . Here is an overview of the key changes you can expect or are already in place :
Unannounced inspections
• Unannounced inspections of manufacturers have already been rolled out
• These cannot be refused or you are at serious of risk losing your CE Mark
• This includes your critical suppliers , and supply contracts will have to be updated
• Manufacturers are well advised to have an SOP detailing the process to follow when the auditors arrive
• Be very aware of fraud attempts , check the identities of the inspectors directly with the NB head office
Clinical Evaluation Reports ( CERs )
• Even though the regulatory requirements have not changed , the rigor given to CERs has increased massively .
• What was acceptable even 18 months ago is unlikely to be acceptable today , expect major non-conformances if :
• You are not in line with current expectations
• You are not up to date with the latest post market information
• Your CERs are more than 12 months old
• Expect a dedicated professional to spend a minimum of 80 hours work on writing a CER for Class IIa / IIb products and 120 hours or more on Class III medical devices
One of the biggest issues of the new regulations will be the reclassification of some devices , including any spinal implants
protection of patients during clinical investigations . Certainly the concept of ‘ equivalent ’ has been overhauled with the buzz phrase ‘ performance is not equivalence ’ being used and for Class III devices one cannot demonstrate equivalence with other manufacturers ’ devices . This means that there will be significantly more clinical investigations being performed , as a way of demonstrating the clinical efficacy and safety of a device .
Unfortunately being prepared for these significant regulatory changes is not only a time consuming and difficult task but it comes with a heavy price tag attached . Some of the main costs that organisations need to account for are : MHRA Surveillance fees , Notified Body fees , punitive damages from the regulator , compensation and punitive damages via the courts and patients , remediation projects , increased requirements ( CER , PMS , Risk & Up-classification ) and professional assistance .
In conclusion , organisations need to be proactive and should have already started to prepare for the new regulatory changes . The main reason behind the changes in regulations is to ensure that medical devices are continuously safe and are of a high standard .
If all manufacturers are meeting these new compliance standards they are paving the way to creating high quality medical devices while creating the right conditions for an innovative competitive market .
Heightened focus on Post Market Surveillance
• Regulatory bodies establishing set requirements for proactive post market surveillance mechanisms rather than simply relying on reactive systems
• Need to ensure that device safety issues are identified as early as possible in the process in order to minimise possible impact on patient / user safety
• Benefits include : reduction in number of complaints , savings on costs associated with handling complaints , safer devices and objective evidence of device safety
Joint audits of NBs
• In order to determine how good , or otherwise NBs are , there is a Joint Audit program whereby routine NBs are observed by the NB Designating Authority , 2 x Competent Authorities and the Food & Veterinary Office
• The net effect is that some NBs have had their approval withdrawn , some NBs have voluntarily withdrawn and some have had restrictions to scope of operations
• Two years ago there were approximately 77 NBs , today there are only 61NBs
• The knock on effect of that is there is now a real shortage of capacity in NBs across Europe . If manufacturers leave their obligations to the last minute they may find no NB can service them in time , leaving them with no CE mark and therefore no product
Reassessment of NBs
• Competent Authorities have been reassessing their NBs and in some cases have been restricting the scope of activities , or limiting the scope of individual Technical Experts
• The net effect is a further reduction in overall NB capacity .
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