Proactivity and due diligence are the key to success for new MDR roll-out, says Peter Rose, Maetrics.
Regulations
After much anticipation the new European Medical Device Regulation (MDR) was published in the Official Journal of the European Union on 5 May 2017. This new regulation replaces both the previous Medical Directive and the Active Implantable Medical Device Directive (90/385/EEC). This new MDR is bringing a significant amount of changes to the medical device industry which means the time is now for manufacturers to sufficiently prepare.
The new MDR has been developed in order to provide a robust regulatory framework to the medical device industry which will ensure a high level of safety while helping to support innovation. It is important to note that the Regulation has binding legal force throughout the EU and enters into force simultaneously in all the Member States.
The changes which this new Regulation will bring will inevitably be very beneficial, however until the roll-out has been completed (by 2020) it is expected that there will be a few bumps in the road for medical device manufacturers.
The significant changes looming:
Reclassification
Certain products have received special consideration in the MDR and are subject to reclassification. These new provisions will apply to cosmetic implants, standalone software, products without an intended medical purpose, certain spine products and reusable Class 1 devices. Manufacturers should determine whether new conformity assessment routes are applicable to their product portfolio and then subsequently engage their notified body and take the necessary steps to make this change.
Market access of legacy products
For any new products to be placed on the market they will have to be CE marked under the new Regulation 2017/745 after the transition period. This means that manufacturers need to be organised to ensure that all products that will be maintained on the EU market will be CE marked in accordance with the full requirements of the new MDR.
Reprocessing of single use devices
A slightly contentious issue throughout the MDR negotiations; the MDR now specifies that the reprocessing and further use of single-use devices should only take place where permitted by national law, while complying with requirements laid down in the Regulation.
Technical documentation
The new MDR is going to be much more prescriptive about the required content of technical documentation, particularly as there are more detailed requirements for Quality Management Systems. Manufacturers will have to ensure that they keep an eye out for the publication of new common specifications.
Clinical Evaluation
The new MDR will require more clinical evidence and clinical evaluation in proportion to the risk associated with a given device. It is advisable that manufacturers plan to review all their CERs if they haven’t already done so in the last 1-2 years and they must ensure that this data includes post market surveillance data.
Vigilance and post market surveillance
When conducting on-going assessments of potential safety risks, manufacturers will now be required to collect post-market clinical data as part of their on-going assessment of potential safety risks. It is also important to note that the reporting time frames have been reduced by half – manufacturers will now have 15 days (compared to the original 30) to report serious incidents.
Mandatory product liability insurance
When it comes to liability, manufacturers must be able to show that they can provide sufficient funds for any potential liability. It is advisable that manufacturers seek legal counsel.
Transparency
A key theme in the new MDR and in order to conform with new transparency requirements, manufacturers will need to notify all products to EUDAMED (European Data Bank on Medical Devices).
Labelling and Supply Change
Every manufacturer will have to appoint a specific person who will assume responsibility for regulatory compliance (PRRC).
Labelling requirements are much more prescriptive, this means that any information which is supplied by the manufacturer must be made available on the manufacturer’s website.
UDI
Under the specifications of the new MDR, all devices will be required to be tracked through a Unique Device Identification (UDI) system, this means that manufacturers will need to properly plan for UDI implementation in the EU. The details about the EU UDI system are still under discussion however it is believed that it will not differ significantly from the newly established US system.
Notified bodies and their changing landscape
It is no secret that over the last few years there have been quite a few safety issues, which means Notified Bodies (NBs) are coming under pressure from their Competent Authorities in order to increase scrutiny on the medical device manufacturers which fall under their remit. This means that NBs will themselves need to seek designation under the new MDR shortly after it is adopted.
The problem is that NBs across Europe are already at capacity and it is expected that this will escalate. In fact there has been a significant decrease in the number of NBs who have been accredited to deal with medical devices regardless of the fact that the new MDR is increasing the workload of the NBs.
This means that there is going to be an immediate over demand from medical device manufacturers for NBs as they demand their services during this challenging transitional period. The new MDR states that once a NB is re-designated they will no longer be able to issue CE marks under the Directive – it is only in the manufacturer’s best interest to ensure that they agree on appropriate timescales.
Other important practicalities of implementation
The harmonising standards and Delegating Acts that will make the MDR operational are still under active discussion and development at the EU level. It is important that manufacturers closely follow these developments by actively engaging with their Trade Associations, and where possible, lobbying to influence their final form.
To complicate things even further manufacturers are going to have to phase in two transitions together as the medical device industry is currently having to transition to the newly revised ISO 13485:2016 standard required for medical device Quality Management Systems.
Steps for manufacturers
There is going to be a substantial administrative burden placed on manufacturers, which means that costing’s for staffing and external requirements should be carefully considered and adjusted to ensure that regulatory compliance is met. It is essential for manufacturers and other economic operators to adopt a pragmatic approach to conformance. It is also highly recommended that a cross-functional project team be formed to manage this.
In conclusion it is clear that manufacturers cannot under-estimate the time that will be required to implement the new MDR. A detailed plan with which is overseen by an assigned project manager will ensure roll-out is as seamless as possible. The challenge is that there are some underlying details of the MDR implementation process which are not fully defined yet. This means not only do manufacturers need to act now, but they need to take responsibility to watch the emerging regulatory landscape. A proactive approach to dealing with the changes will ensure the medical device market will be populated with high performing and safe devices