By Marc Southern
The discovery of non-medical medical grade silicone in breast implants in 2010 was one of the key triggers that began the process to overhaul how medical devices came to market in Europe***.
In light of the PIP breast implant scandal, the European Commission and EU member states took immediate action to tighten controls and ultimately provide a better guarantee of the safety of medical devices to the public. This culminated in the so called Dalli action plan, which looked to address the correct functioning of notified bodies, how surveillance of devices was conducted, how vigilance should be managed, as well as how ongoing monitoring should be done in a clear and transparent manner. As John Dalli, EU health commissioner said at the time “We must do our best never to let this happen again.”
It is too early to talk about the impact of the new regulations as implementation will likely start later this year. However, a look back at the past four years following the Dalli action plan highlights the large effort now required by the manufacturers and notified bodies in each member state. Are notified bodies learning to cope with with this new regulatory environment, or is it becoming harder for companies to interact effectively with notified bodies? A large proportion of medtech companies are SMEs (small and medium sized enterprises) that don’t have unlimited resources. It is therefore imperative to plan more effectively to mitigate the risks that currently exist in this regulatory landscape.
***Poly Implant Prothèse (PIP) was a French company that produced silicone breast implants. The company was found to be illegally manufacturing and selling breast implants made from cheaper non-medical grade silicone. These implants were found to have higher risk of rupturing or leaking than other implants. This led to the recall of the implants in 2010 and a review of regulations in the Dalli action plan.
A key component of the Dalli action plan was the recommendation for notified bodies to scrutinise manufacturers post approval. This took the form of inspections/audits of the specific products being manufactured. These spot checks of unannounced factory inspections have started and there are some learnings on how these could be better managed. There are several considerations to be aware of when interacting with notified bodies regarding this:
- Review your supply chain – Notified bodies have the right to audit or inspect your subcontractors and suppliers. It is important that you identify your key suppliers and subcontractors so that you can re-negotiate your contracts with them to include language for them to participate with a notified body inspection
- Contractual agreements – It is also prudent to discuss and if needed explain these contracts to the notified body, so it is important to involve your legal advisors in this process and ensuring that they have a good understanding of the regulatory implications of these contracts
- Communicate effectively – Starting a dialogue with the notified body can help streamline the process and make it more efficient for you and the notified bodies. In particular, attention should be given to practical aspects, for example, when are your sites open, and importantly when are your subcontractor/supplier sites open, is it a local holiday in their market? Other areas to address include the costs of the inspections, these should be discussed in relation to a contractual agreement with the notified body
- Fair costs – When communicating with notified bodies, you should discuss the cost of inspections. You need to ensure that you are not out of pocket financially for the cost of the inspection. For example, if the notified body hires additional expertise to accompany them to a site inspection outside the EU, there need to be clear recommendations agreed regarding acceptable levels of cost for the visit. These elements can be built into a contractual agreement with the notified body
Vigilance reporting and market surveillance systems
Another important aspect from the Dalli action plan is the requirement to improve the functioning of the vigilance system required to monitor the safety of medical devices. These improvements aim to encourage the correct reporting of adverse events and in the coordination and analysis of these reports. There are several aspects to vigilance and surveillance that are important to point out as they are still being worked through and can be the cause of delays when interacting with notified bodies. These are outlined below:
- Data collection and processing – adverse event information will need to be collected and coordinated with the notified body and ultimately added to the vigilance database managed at EU level, the electronic vigilance system (EUDAMED). Manufacturers should continue to plan and anticipate the impact this level of reporting will have on company resources, for example the increased burden of reporting and the need for a qualified person responsible for regulatory compliance. Companies should conduct an analysis of current practices and open dialogue with the notified bodies to ensure that they are tracking the correct information (adverse event types, complaints, etc.) and setting policies outlining the correct standards
- Better coordination and communication – manufacturers are responsible for ensuring adequate follow up of the quality, performance and safety of devices that they have placed on the market. Mechanisms to help improve these process are coming into place. It is advisable to better understand the level of reporting that is required. Conduct a gap analysis of what you currently report on and what is likely needed. This should be done in collaboration with your notified body
There is no question that the Dalli action plan was the beginning of several changes in the EU regulatory framework for medical devices. With the new medical device regulations being developed to ensure, an emphasis on clinical aspects, and an alignment of the enforcement of rules across EU member states.
Medical devices are vastly different from one another and cover numerous areas, this adds to the challenge that those approving the new regulations must consider. The goal must be to ensure that safety to the patient is paramount, but mustn’t stifle innovation. There will be a learning curve as notified bodies and manufacturers get to grips with the new regulations. It is vital that you continue to reach out to your notified body to talk about what they expect and how you can be prepared to comply with the new legislation. Communication and expectation management will enable you to effectively work alongside your notified body to create healthcare solutions.