Euro Roundup: Commission delays notified body reassessments to free up capacity for MDR, IVDR

The European Commission has published delegated regulations to change the frequency that notified bodies are reassessed under the new device and diagnostic regulations.
 
Under the original Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), notified bodies designated to certify devices under the rules needed to be reassessed three years after first being notified and every four years thereafter. The need to free up time at existing MDR/IVDR notified bodies and focus authorities’ resources on new assessments led the Commission to rethink the requirements.
 
The publication of the delegated regulations resets the period between assessments to five years. The new timeline has now taken effect, although some notified bodies may still undergo assessment more frequently than every five years. 
 
Complete reassessments that began before 11 March will continue, unless the designating authority decides to suspend or terminate the process in light of its resources, the resources the notified body has already spent on reassessment and the results of annual assessments. The delegated regulations also give designating authorities the power to perform reassessments more frequently if needed.
 
MDR Regulation, IVDR Regulation
 
EMA finalizes guidance on computerized systems and electronic data in clinical trials
 
The European Medicines Agency (EMA) has finalized a guideline on computerized systems and electronic data in clinical trials. EMA’s document, which replaces a reflection paper on the same topic, is intended to help stakeholders adapt to increases in the complexity of computerized systems that have happened in recent years.
 
In setting out the need for guidance, EMA pointed to the rapid changes that have occurred as electronic case report forms, electronic patient reported outcomes, wearable devices and artificial intelligence have become part of the clinical trial landscape. EMA has designed the guidance to help stakeholders use the new technologies while ensuring the quality and reliability of trial data, and the rights, dignity, safety
and wellbeing of trial participants.
 
That goal has manifested in a 52-page document that defines key concepts such as data integrity before discussing points specific to computerized systems and electronic data. The computerized system section covers topics including training, security and access control, and timestamps, while the electronic data section addresses data capture, audit trails, certified copies and more.
 
Six annexes take up almost half of the document. In those sections, EMA discusses contracts related to computerized systems and services, validation, user management, security and clinical systems in more depth. The section also features an annex focused on considerations that are specific to electronic clinical outcome assessments, interactive response technology systems and electronic informed consent.
 
The annexes have undergone extensive changes since EMA released a draft version of the guideline for consultation in 2021. EMA has added a new annex on clinical systems, in which it discusses additional considerations regarding electronic medical records and other systems at sites that are primarily used in clinical practice but are also generating clinical trial data.
 
EMA also made significant changes to the existing annex on the validation of computerized systems. The final text states that “the responsible party should ensure that systems used in clinical trials have been appropriately validated and demonstrated to meet the requirements defined in ICH E6” and outlines what to do if a service provider releases a new or updated version at short notice.
 
If the responsible party lacks time to validate the system, the guidance states that “it is particularly important for the responsible party to evaluate the vendor's process for validation prior to release for production, and to strengthen their own periodic review and change control processes.” The responsible party should not use new features until it has validated them or reviewed and assessed the vendor's documentation.
 
The guideline will take effect in six months.
 
EMA Guideline
 
EMA agrees to strengthen cooperation with health emergency body, share data and tools
 
EMA has agreed working arrangements with the Health Emergency Preparedness and Response Authority (HERA) to strengthen its cooperation with the recently established body. The arrangements cover the exchange of information and access to IT systems and tools in areas of shared interest.
 
The non-binding agreement states that EMA and HERA will organize joint meetings, provide access to information systems and other IT tools, and exchange scientific expertise related to cross-border threats.
 
HERA and EMA have identified five specific areas of cooperation: assessment of cross-border threats to medical countermeasures; identification of medical countermeasures; identification of vulnerabilities in the supply of medical countermeasures; coordination on medical countermeasures in emergencies; and reinforcing the global health emergency preparedness and response architecture.
 
The collaborators have provided information on how they will work together in each area, explaining, for example, that EMA will help HERA identify risks of shortages for specific medical countermeasures and that HERA aims to ensure “the interoperability of its Intelligence Gathering Platform with existing or future EMA IT systems.”
 
Press Release, Working Arrangements
 
Kyriakides outlines aims for contentious EU pharma reforms, prioritizes leaner regulatory environment
 
The European Commissioner for Health and Food Safety has set out key aims for the EU pharmaceutical legislation at an event to discuss the proposal. With the industry pushing back strongly against a leaked draft, Stella Kyriakides used the event to make the case for the reforms.
 
Kyriakides addressed concerns that the legislation will stymie innovation, stating that ensuring that the EU is globally competitive is a top priority. “We will make sure we give strong incentives for innovation, especially for unmet medical needs,” Kyriakides said, and reward companies that “go the extra mile to provide EU-wide access.”
 
The Commissioner acknowledged that there is a “balancing act,” with the goal being for “innovation to serve every patient, equally and equitably, across the EU.” Kyriakides also discussed reforms to address drug shortages, the sustainability of medicines, antimicrobial resistance and the creation of a leaner regulatory environment.
 
Kyriakides’ goal is to create “a leaner regulatory environment for investment with simplified and faster marketing authorization procedures, stronger support for promising medicines and better use of data and digitalization.”
 
The EU is set to publish its proposals this month.
 
Speech Transcript, Meeting Recording
 
EMA, under political pressure, outlines support for the development of psychedelics
 
EMA executive director Emer Cooke has set out the agency’s approach to psychedelic-assisted therapies in response to a call from politicians for the regulator to play a more active role in the area.
 
Replying to a letter from Members of the European Parliament, Cooke said EMA has encouraged all developers of psychedelic therapies to engage with regulators in the European Union. EMA and members of its Central Nervous System Working Party are scheduled to take part in a conference on psychedelics next week and are planning a multi-stakeholder workshop for later in the year.
 
The workshop will focus on “promoting the development of psychedelics that address unmet medical needs,” Cooke said. Cooke made the comments in response to concerns that the EU is failing to keep pace with the evolution of regulatory attitudes to psychedelic-assisted therapies in the United States and Australia.
 
EMA Response
 
Other News:
 
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has joined the wave of regulators withdrawing pholcodine over-the-counter cough and cold medicines over the risk of anaphylaxis. MHRA Notice