The Medical Devices Regulation has created some turmoil for manufacturers, particularly smaller companies, as they try to navigate a host of new requirements.
Devices that previously would not have had to undergo conformity assessments with the notified bodies may now be classed differently and require assessment. That adds an extra layer of cost and complexity, particularly given most medical devices don’t yield huge profits. With this in mind, some smaller manufacturers are reviewing their portfolio to assess whether they can justify moving forward with MDR.
Another key consideration is whether they have the expertise to comply with the regulations over the long term, since MDR requires having experienced resources to maintain the technical files and stay up to date with changes.
Finding a notified body
On top of that, there is the challenge of finding a notified body if you don’t already have one – particularly given that fewer than 40 notified bodies have chosen to pursue MDR accreditation, compared with 96 under the Medical Devices Directive.
Engaging a notified body can be a very time-consuming process. It can take as much as six to nine months simply to get a contract signed. Then, the first thing that the notified body will do is assess the manufacturer and look at the quality management system, just to see whether they can comply with MDR, before they even look at any devices.
It’s only at that point that the notified body will start looking at the devices and the technical files to make sure all the information is there, that there is a risk management plan, assess the safety profiles and look at clinical data and feedback.
With all this in mind, it could take up to a year for them to get certified with the product and as much as two years from trying to get contracts in place to certification, depending on the complexity of the product.
Many companies are dealing with uncertainty and are in a holding pattern as they wait to find out how the recent delay to MDR transition dates will affect them, and, in many cases, whether they can engage with a notified body.
Concerns we have heard range from whether they can get their devices certified to worries that if their products are classed under a higher category they will have to conduct clinical investigations and performance studies throughout the lifecycle of their product.
They often aren’t sure whether what they have done already will be enough to generate clinical data for the product and maintain their certification under MDR, or whether they will face the expense of clinical trials.
Furthermore, since MDR is new to most companies, few have people with the experience or knowledge to manage risk assessment and clinical data. Most small companies are struggling to come up with a lifecycle plan on:
- how to collect data
- who will conduct data collection
- what form data collection will take
- whether their data will measure up under MDR
All of this is a huge undertaking, requiring specialist expertise that largely isn’t available to smaller, resource-strapped companies.
Finding alternative options
With these issues to contend with, several smaller companies are looking to less difficult markets to launch their products. One market that seems to be benefiting greatly from this is the US, which has clear, well-established processes for medical devices.
One other possible approach for these small innovator companies would be to consider the UK, which currently is still on the directive. Launching or registering their product in the UK can certainly be a less complex way to bring a product to the market and companies can take the opportunity to gather data for a later launch in the EU.
“Depending on how big the manufacturer is, it could take up to a year for them to get certified with the product and as much as two years from trying to get contracts in place to certification.”