The European Commission has proposed targeted reforms that are aimed at simplifying the rules for medical devices. The proposed reforms are part of the package of measures that have been put forth by the Commission recently so as to advance the biotechnology sector, upgrade the access when it comes to cardiovascular treatments, and also streamline the medical device regulation.
On 16 December, the Commission went ahead and proposed a measure so as to increase the investments in terms of biotech products in order to aid their advancement to the market and a plan to address the cardiovascular diseases within the economic zone. Besides this, it also proposed a new regulation in order to streamline the regulatory pathway when it comes to medical devices.
According to the Commission, the December 16 proposals are indeed going to simplify the EU rules when it comes to medical devices, support the digitalization in terms of procedures, and also offer a coherent framework so that the companies can very well respond to the changing market conditions and also patient requirements. In order to speed up the access to medical devices and also guarantee a consistent supply, timelines to complete the conformity evaluations are going to be introduced.
The commission further added that a stronger role for the European Medicines Agency – EMA is going to surely strengthen the coordination at the EU level, while the companies are going to be offered more scientific and technical expertise, along with regulatory expertise. The EMA is also going to track shortages pertaining to medical devices, and a list of critical devices is going to be created.
The proposed changes go on to include eradication of detailed qualification requirements for the person responsible for regulatory compliance – PRRC and also easing the needs pertaining to small- and medium-sized enterprises -SMEs to have a PRRC in place consistently, removing the maximum 5-year period that certificates happen to be valid, enabling much more flexibility within the types of clinical data that are qualified, coming up with a new benchmark for well-established technologies that are going to be regulated in a more proportionate way, and altering the classification rules so as to reduce the risk of certain devices.
The Commission also went ahead and noted that since Medical Device Regulation – MDR and In Vitro Diagnostic Regulation -IVDR were adopted, their execution deadlines have been repeatedly extended in order to prevent any potential product shortages and enable more time for notified bodies as well as the manufacturers to catch up. But, it said that its proposed reforms are intended to go ahead and address the underlying structural challenges with the regulations.
This proposal looks forward to streamlining and also future-proofing the regulatory framework remarked the Commission. Its main aim is to go ahead and simplify the applicable rules, decrease the administrative burden when it comes to manufacturers, and also upgrade the predictability as well as cost-efficiency of the certification procedure through notified bodies, while at the same time preserving a high level of public health protection as well as patient safety, and hence to help attain the initial objectives of the regulations.
The Commission further notes that this proposal is a response to the requests from the European Parliament, numerous Member States, and also many stakeholders for simplification of the regulatory framework pertaining to the medical devices and also for measures to make sure of the availability of devices. A new regulation is required to remedy the challenges that have been identified, which otherwise would have a major effect on the medical devices market and, thereafter, on the healthcare quality provided to the patients in the EU.
Among the many reforms, the Commission said that the proposed alterations are sure to decrease the administrative burdens and also enhance the coordination between regulatory actors through creating more efficient reporting needs, simplifying the regulatory rules, and also making the regulatory process seamless. It also said that the conformity evaluations are going to be more proportionate as well as targeted, breakthrough technologies are going to receive more support, it will also offer more legal certainty along with predictability to the manufacturers, enhance coordination at the EU level, and also streamline the oversight of notified bodies, and thereby reinforce the cooperation needed with the global regulators.
Among the changes by the commission to reduce the administrative burdens, it also went on to propose narrowing the scope of the summary when it comes to safety and clinical performance, which needs to be submitted to the devices where the notified body has to conduct a technical documentation evaluation. It said that the notified bodies would no longer be required to submit a separate validation for these devices.
Moreover, the Commission also proposed decreasing the requirement to submit the periodic safety update reports – PSURs and also stated that they would get integrated within their surveillance activities. In addition to this, manufacturers would have 30 days in order to report certain serious incidents and not 15 days, and notified bodies can also agree on a predetermined change control plan – PCCP with the manufacturer to enable specific changes to their product without any prior notification.
As part of the reforms, the Commission also went on to propose setting maximum timelines for the notified bodies in order to complete their conformity evaluations. It also floated reforms that were targeted at making sure of timely certification for breakthrough medical technologies.
Medtech Europe, the lobby group, welcomed the proposed reforms while at the same time noting that they do not go far enough.
Medtech Europe said that the MDR and IVDR have each gone on to strengthen the EU regulatory system when it comes to medical technologies. At the same time, their structural deficiencies have also led to certain serious unintended consequences, which include certification bottlenecks, decreased availability of products for patients, and also unsustainable pressure on the SMEs.
The group further added that revising what is not working to the mark, while at the same time preserving what is already functioning effectively, is hence both necessary and timely.
While Medtech Europe said that the streamlined governance structure that has been proposed by the Commission is indeed a good step, it also argued that it did miss the opportunity to create a single governance structure. It also went on to praise the proposed regulatory simplifications, but again said that they did not go far enough.
Medtech Europe also opined that there are many improvements that are proposed in order to increase the efficiency of the system, including extending the validity of the certificates, making the reporting more risk-based, simplifying the management when it comes to product changes, and also taking into account more digitalization. Still, the lack of early clarity when it comes to clinical evidence expectations does lead to unpredictability, unnecessary rework, and also delays in terms of making the devices available to the patients.
All the legislative proposals are going to be submitted to the European Parliament and Council for review as well as adoption. The Commission went on to state that it will also partner along with the Member States in order to initiate the execution when it comes to proposed reforms.