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After weeks of heightened speculation, the European Council has agreed on its approach to new medical devices and in vitro diagnostics (IVD) legislation.
Regulators in Europe have been discussing the need to reform the legislative framework for medical devices and IVD for many years.
In the EU, the legislative process is structured so that only the EC can initiate new legislation. The European Parliament then votes on the commission's proposal and legislative texts, making any amendments it chooses. Once the parliament has adopted a proposal, the European Council is tasked with adopting a general approach before beginning a trilogue with the parliament and commission to work toward a final text.
In 2012, after a multiple public consultations, the European Commission (EC) released two proposed regulations, one each for medical devices and IVDs. According to the commission, the goals of the new regulations were to deliver greater consistency and safety to patients, and to bring medical device and IVD legislation up to speed with technological and scientific advancements that took place in the 20 years since the current legislation was adopted.
Over the next two years, the parliament and commission went back and forth on the proposed texts, before the parliament adopted the proposed legislation in April 2014.
The EC originally predicted new medical devices and IVD regulations to pass through the council and parliament in 2014.
Instead, the discussions have lasted into 2015, with some speculation that the council may not adopt a general approach before the Latvian presidency ends this month. However, at the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council meeting last Friday, the European Council adopted a general approach.
After the council adopted its approach, European Council President Guntis Belēvičs, called the move "a decisive step forward to improve patient safety and strengthen European competitiveness."
Much of the council's approach is similar to what the parliament and commission have proposed. However, the council has highlighted several areas for increased scrutiny, including notified bodies, postmarket surveillance and clinical investigations.
Under the council's approach, notified bodies will undergo a stricter designation process and increased monitoring by competent authorities. Additionally, notified bodies would be given the authority to "carry out unannounced factory inspections."
Manufacturers will also face increased postmarket surveillance requirements compared to the commission text. Manufacturers will now be required to form a postmarket surveillance system "proportionate to the risk class and appropriate for the type of device." Companies will also be required to submit periodic safety update reports (PSURs), similar to pharmaceutical reporting requirements, on an annual basis. Manufacturers will also be required to act faster in response to serious public health threats or deaths caused by devices.
Finally, the council has amended the commission's proposed texts to include greater protections for patients in participating in clinical investigations for medical devices.
To demonstrate conformity, companies must demonstrate that their products have an acceptable benefit to risk ratio. For high-risk devices, companies must provide conduct clinical investigations to demonstrate their product's safety and performance. The council proposal includes a provision to allow manufacturers of class III (highest risk) devices to consult with an expert panel to provide feedback on the company's clinical investigation strategy. The regulation also provides criteria for, and restrictions on, clinical investigations, and allows for individual member states to further restrict certain practices within the scope of a clinical investigation.
Following the release of the council's general approach, industry group MedTech Europe released a statement welcoming the progress made at the council. However, the group has come out against several provisions of the proposed legislation.
First, the group says the additional scrutiny by competent authorities will create redundancies for companies, which will already be subject to greater oversight by notified bodies under the new legislation.
Predictably, MedTech Europe has come out against provisions in the proposal which would allow single use devices to be reprocessed and used by other entities, such as commercial reprocessors or hospitals. While the group says allowing single use devices to be reprocessed could endanger patients, reprocessing such devices would also cut into the sales of new medical devices.
For IVDs, MedTech Europe is appreciative of the five-year transition period before new legislation would take effect. However, the group finds the clinical evidence requirements for IVDs to be too burdensome, with "unclear benefits for patients." Additionally, the group says the definition for companion diagnostics is "too broad to be functional," and would encompass many simple diagnostics such as cholesterol tests.
European Council Press Release, Medical Devices Legal, Council Proposal Medical Devices, IVDs
Tags: European Council, EPSCO Council, notified bodies, clinical investigation