Innovations Into Success Summer 2016 | Page 52

Medical Devices
Hip implant vigilance failures have led to the recent changes to the rules governing medical devices
currently remain uncertain . In fact there are a total of 43 Delegated Acts that must also be implemented following the publishing of the MDR in the official journal . Of these two significant issues are the timing of the EUDAMED database and Unique Device Identification ( UDI ) requirements . UDI has already been implemented in the US and a version will be rolled out in Europe too , but this cannot begin until the MDR is published . EUDAMED is a central European databank that is only accessible for competent authorities and is used to manage and analyse data relating to clinical investigations , vigilance reporting , device / manufacturer registrations and certifications , and market surveillance .
Looking to the new MDR itself , one of the biggest issues will be the reclassification of some devices . Certain devices are to be up-classified to Class III devices , meaning that the Technical File will now need to be converted to a Design Dossier , a Design Examination certificate will be required from the Notified Bodies and all design changes must go through a formal design process with anything other than minor changes being approved by the Notified Bodies . Some examples of these devices are : in vitro contact with cells , Apheresis devices , spinal implants , total and partial joint replacements , nanomaterial devices , AIMD accessories and devices which are intended to be introduced into the human body via a body orifice or applied on skin that are absorbed by or locally dispersed in the human body .
The requirement for a ‘ Qualified Person ’ remains unchanged except for the name change to a ‘ Person Responsible for Regulatory Compliance ’ ( PRRC ), presumably so as not to confuse with a pharmaceutical QP . The PRRC does not have to be directly employed by an organisation but must be permanently and continuously at their disposal , meaning a contract must be in place and there are no causal appointments on an ‘ as needed ’ basis . The PRRC must have either a relevant degree and two years ’ experience in a regulatory or quality role relating to medical devices ; or if they don ’ t have a degree then five years ’ experience in a regulatory or quality role relating to medical devices is required .
In addition to the changes already implemented for Clinical Evaluation Reports ( CERs ), there are also proposals in the draft MDR to significantly change the requirements for Clinical Evidence . There is much more emphasis on patient safety with improvements to data robustness and

Case study

A large multinational medical device manufacturer , with operations around the globe including multiple US locations and multiple EU locations , is aware of the potential impact on the organisation as a whole and on the individual business units .
The company has appointed a global champion to assess the specific impacts of the changing regulations on all products and manufacturing sites where CE marking is relevant . This individual is working closely with the latest draft text of the MDR and with the key trade organisations to stay completely up to date with the proposed text and discussions on amendments to the text . An action plan is being built at a corporate and individual site level .
Once the final text is published ( expected Q4 / 2016 ) the plans will be re-assessed , amended and finalised before being setting a final budget and then rolled out to a team of regulatory experts to implement the plan , both globally and locally .
Priority is being given to the highest cost and longest lead time activities ( with respect to the company concerned , different companies will have different priorities ), which are clinical evidence , UDI , SVHC , reclassification and Quality Management System ( EN ISO 13485 ) requirements .
52 SUMMER 2016