The new regulation surrounding medical devices came into force on 25th May 2017 and is set to make some major changes to the industry over the coming years and will be compulsory from May 2020 for the MDR and May 2022 for the IVDR.
One thing that struck me whilst reading through articles detailing all the necessary changes was the employee numbers needed to implement and manage so many amendments. Recruitment will vastly grow in parallel with these changes being adopted. The additional functions have created new responsibilities and roles that in most cases will not be able to be satisfied by the present numbers. This blog will focus on the main changes and the how they will affect the job roles and opportunities in this sector.
Probably the first change to mention is that this is now a REGULATION and is four times longer than the directive it replacements, perhaps highlighting the scope of the changes.
New Products Added
Aesthetic devices will now be included. Products such as coloured contact lenses and fillers that don’t actually provide a medical function, will now need to adhere to the MDR. Similarly, any bi-product or accessory that is used to clean, disinfect or sterilise a medical device will also need to be compliant. These products have so far not been regulated in this way and this adherence will be a large undertaking.
It is now mandatory to nominate a Responsible Person (RP) who will be in charge of regulatory compliance and the minimum experience, both academic and commercial, they will need to have in order to fulfil this role is also set out in the MDR;
a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, in law, natural sciences, medicine, pharmacy, engineering or another relevant discipline; and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices
four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
This addition is bringing the medical device sector in line with the pharmaceutical industry and the appointment of a Qualified Person (QP)
It will be mandatory to use a Quality Management System (QMS) and it must be submitted to a notified body for review and assessment. This submission will also need to include details of the company’s quality objectives, procedures for monitoring, verifying, validating and controlling the design of devices and how this will remain adequate and effective throughout the lifecycle of the product. The MDR also stipulates that any planned changes to the QMS must go through the appropriate notified body to ensure continuing compliance.
Clinical Data Evaluation
Prior to the MDR Clinical Evaluation could be displayed via a clinical literature review, performing a clinical study or a mixture of the two. However, the MDR provides much more stringent measures to satisfy this and again Notified Bodies will play a more integral part in this process, not just from an approval point of view but also providing guidance on new procedures.
Under MDD, a list of equivalent products already on the market was sufficient, however now the manufacturer must submit an in-depth analysis of one competitor product, considering clinical and technical characteristics but also photos or drawings to compare shape, size and the contact it has with the body. It is also a necessity to update clinical data regularly, with higher classed devices being reviewed annually at the very least. EVERY device’s clinical evaluation data must be updated every five years.
As with the RP requirement the MDR states minimum experience levels for those to be involved. Evaluators must have experience within clinical study design, information management, medical writing and regulatory requirements in addition to a higher education degree in this subject area and 5 years of industry experience (or 10 years’ experience without the degree qualification)
Re-certification and Re-classification
Devices that had achieved CE marking under the MDD will need to be re-certified under the new regulation and again manufacturers have 5 years to become compliant. Wholesalers will be able to continue to distribute these products as is, but manufacturers will only be able to continue to make these products for four years and will be subject to the post market surveillance requirements of the MDR and any other pre-market requirements that were set out in the old MDD. Also many devices will now fall into a different class under the MDR and will now need to be re-classified.
In vitro Diagnostic (IVD’s) devices are classified into four risk categories, but the MDR has increased the interaction required with notified bodies for these types of device. Under the MDD around 10% of these devices need to be audited by such a body – the MDR will see this increase to around 90%.
Due to this it is unsurprising to hear that notified bodies will work in even closer collaboration with medical device manufacturers under the MDR; including unannounced audits at least every five years and monitoring activity on an ongoing basis.
Identification & Traceability
The MDD made no provisions at all for the traceability of medical devices and this introduction does not only set out regulations for manufacturers but also those in the supply chain and even healthcare professionals.
UDI (Unique Device Identification) details must be visible on the label and/or packaging of the device. This number denotes the manufacturer but also a number unique to that particular device and this must be submitted to a central European database (EUDAMED) and in time this will be followed up with post market surveillance, safety and clinical information. This database will be central to monitoring devices in the long term. Including storage of the devices and how it has been tracked during distribution.
Post Market Surveillance
This term appears in the MDR one hundred and twenty-nine times! Post market surveillance data will be a new component of the QMS and will document the manufacturers plan and updates regarding vigilance and trend reporting, information from patients including complaints or undesirable side effects and non-serious incidents. The view is that this will cover quality, safety and performance of the device and the collection of data in one central database will make it easy to analyse and implement changes expediently and efficiently.
My original premise for this blog was to look at the new roles that have been, and continue to be created due to the MDR. From looking at some of the key changes it is clear to see that recruitment will rise as this grace period continues. The introduction of an RP creates a new role function within medical devices and experienced regulatory professionals are going to be sought after as medical devices manufacturers work to ensure their compliance. The increase in necessary depth within clinical evaluation creates roles for clinical study professionals and medical and regulatory writers. Public access and the necessary updates to EUDAMED for the additional data will also create jobs and the increasing collaboration between medical device companies and notified bodies will also create new opportunities in terms of auditing staff and additional personnel needed to review 90% of IVD’s on the market.
There is no doubt that the MDR is extremely beneficial for ensuring the quality and safety of medical devices already on the market and those within the pipeline. It will also provide new career opportunities and avenues for skilled professionals.
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