Euro Roundup: UK delays new Medical Device Regulations by 12 months

RoundupsRoundups | 27 October 2022 |  By 

The UK has delayed the implementation of the future Medical Device Regulations as part of the government’s commitment to an approach that “supports system readiness and minimizes the risk of supply disruptions.” The target date for the new regulation is now July 2024.
 
The government framed the delay as part of its commitment to “ensuring that there is a proportionate approach to its implementation” that reduces the risk of disruption. The Medicines and Healthcare products Regulatory Agency (MHRA) also recently extended its use of an EU-reliant approval process by 12 months.
 
MHRA also provided an update on the transitional arrangements. Under the previously published regulations, England, Scotland and Wales, known collectively as Great Britain, planned to stop accepting CE-marked devices on 30 June 2023. The situation in Northern Ireland, the other member of the UK, is different because of the terms of the Brexit agreement.
 
The government outlined its approach to transitional arrangements over the summer after reviewing the responses to a consultation. In the spring of next year, officials will introduce legislation to bring the transitional arrangements into force.
 
The legislation will also bring postmarket surveillance requirements into force. “Bringing into force the new postmarket surveillance requirements ahead of the wider future regulatory regime reflects the government’s priority of improving patient safety as part of the future Medical Device Regulations,” the update states.
 
MHRA Notice
 
Claiming feedback is ‘largely ignored,’ EFPIA calls for talks with Commission on HTA regulation
 
Pharma trade group EFPIA has called for the European Commission to enter a “constructive” dialog about the regulation on health technology assessment (HTA). EFPIA made the statement after becoming concerned that comments on guidance documents “remain largely ignored.”
 
Late last year, the HTA Regulation cleared the final hurdle in the legislative negotiations, leading EFPIA to express “regrets that the original ambition set forth by the European Commission in its original proposal has been diluted” and warn it could yield “an unpredictable system.” Since then, EUnetHTA21, a group of 13 HTA agencies convened by the Commission, has published draft guidance to support implementation of the regulation. EFPIA and EUCOPE, the trade group for smaller drug developers, criticized the process.  
 
“More than 400 comments provided by various stakeholders’ organizations have had little to no impact in the preparation of the guidance, with only a few lexical changes made in the final published document,” the trade groups wrote. “We worry that the lack of consideration and openness towards the contribution of stakeholders may undermine not just the quality of this important preparatory work but also the ability to deliver on all the objectives of the HTA Regulation.”
 
The worry stems from the belief that the implementation process may “lose sight of the objectives of the EU HTA Regulation,” notably the intention to establish a predictable and more effective system for joint clinical assessment. EFPIA and EUCOPE think the goal is still achievable, provided “there is appropriate interaction between industry, patients, clinicians and HTA agencies” on the process.
 
EFPIA Statement
 
EMA posts information about proof-of-concept pilot of raw data submission and analysis
 
The European Medicines Agency (EMA) has shared details of a proof-of-concept project that will pilot the submission and analysis of raw data – also known as standardized study data -- from clinical trials.
 
Currently, the Committee for Medicinal Products for Human use (CHMP) mainly assesses data from clinical summaries and information in clinical study reports. As EMA explained, “this data is provided in a format that does not directly allow disaggregation or any other form of further analysis.”
 
The pilot began last month and will run for up to two years; EMA aims to receive around 10 applications during that time. The pilot is open to initial marketing authorization applications and post-authorization applications in all disease areas.
 
Applicants can email EMA to express an interest in participating in the pilot program. CHMP rapporteurs will decide whether to include a procedure in the program. The analyses will either be handled by the CHMP rapporteurs, EMA staff or contractors working to the same standards of data security as in-house employees. Participation in the program will not delay CHMP’s adoption of the scientific opinion.
 
EMA Notice
 
EFPIA joins with 28 bodies to share recommendations on the European Health Data Space
 
EFPIA, MedTech Europe and other bodies have issued joint feedback on the planned European Health Data Space (EHDS). The 29 bodies support EHDS but want officials to address “important details” in the “broad-sweeping proposal” to ensure it meets its objectives.
 
Across the seven recommendations, the groups call for EHDS to “align with all relevant horizontal and sectoral European laws” and for the “harmonized interpretation and implementation of the Regulation across the EU.” The bodies identify alignment with the Clinical Trial Regulation, Medical Devices Regulation and In Vitro Diagnostic Regulation as “a must.”
 
The focus on harmonized interpretation and implementation across the EU reflects a concern that, in the absence of “clearer descriptions of the data in scope,” the project could deliver “27 fundamentally different data spaces,” one for each member state. EFPIA and its cosignatories also want legal and ethical criteria for approving pseudonymised data use and data linkage to be specified at the EU level.
 
Other recommendations cover the need for a broad range of stakeholders to be “strongly involved” from the start of the process, the importance of clearly defining the scope of electronic health record systems and the value of leveraging existing health data infrastructures to “allow continuity and build on existing expertise.”
 
Joint Recommendations
 
Sanofi recalls antibiotic from UK after bacterial endotoxins cause high fever in 4 patients
 
MHRA has asked patients using Sanofi’s antibiotic Targocid to check the batch number after four people experienced high fevers after taking the treatment. Patients with products from the two affected batches should stop treatment and immediately seek medical advice.
 
The two batches of Targocid 200mg powder for solution for injection or infusion contain high levels of bacterial endotoxins, a compound in bacterial cell walls that can cause inflammation-related symptoms, high fever and septic shock. Typically, the drug is given in hospitals by healthcare professionals, but it is prescribed to some patients for home use. MHRA wants patients with prescriptions to check their packs.
 
“It is vitally important that you check the labels of your Targocid 200mg powder and if the batch number is 0J25D1 or 0J25D2, you should stop using the medicine and seek immediate medical advice from a healthcare professional. If you are unsure which batch you have been given to use at home, please seek medical advice,” Alison Cave, chief safety officer at MHRA, said.
 
MHRA Notice
 
Other news:
 
The European Commission's Health Emergency and Preparedness Response Authority (HERA) and the Coalition for Epidemic Preparedness Innovations (CEPI) are strengthening cooperation and information exchange on vaccine R&D and manufacturing, both within the EU and overseas. Press Release

 

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