Euro Roundup: EU issues implementing regs for devices without an intended medical purpose

RoundupsRoundups | 08 December 2022 |  By 

The European Union has published implementing regulations to lay down common specifications and rules for reclassification of products without an intended medical purpose under the Medical Devices Regulation (MDR).
 
MDR features an annex that lists groups of products such as contact lenses, dermal fillers and liposuction devices that lack an intended medical purpose but are still subject to the regulations. The regulation is written to apply to the products “taking into account the state of the art, and in particular existing harmonized standards for analogous devices with a medical purpose, based on similar technology,” and states common specifications shall address risk management and, if necessary, clinical safety evaluation.
 
While the regulation provides some information about what is expected of manufacturers of the class of products, noting that clinical evaluations shall be based on safety data such as post-market surveillance and, where applicable, “specific clinical investigations,” it lacks some key details. The new implementing regulations fill in the gaps.
 
In the common specification implementing regulation, the EU provides details of the requirements that apply to all products without an intended medical purpose and to specific groups of such devices named in MDR. The universal specifications focus on risk management, a topic that is broken up into sections on general requirements, risk management planning, identification of hazards and risk analysis, risk evaluation, risk control and evaluation of residual risks, review and production and post-production.
 
The section explains that risk management planning documents shall include a list of the activities to be performed in each step of the risk management process, references and description of the device and a specification of the life cycle phases of the device covered by each activity included in the plan. To meet the risk evaluation requirements, companies need to assess the estimated risks and determine whether they are acceptable in accordance with the criteria established during risk management planning.
 
A shorter section of the document provides information for safety, including specific points about the label and instructions for use, and the rest of the text covers requirements that are specific to different types of products without an intended medical purpose. Manufacturers of contact lenses, for example, need to consider “the shape of the device, in particular in view of avoiding irritation” and the “increased risk of eye damage if the lenses are worn extensively.”
 
Transitional provisions apply to the common specifications. Manufacturers that are performing, or plan to perform, clinical investigations to confirm conformity with relevant general safety and performance requirements can continue to place products on the market until 22 June 2028, provided two conditions are met. First, the product must have been lawfully marketed before 22 June 2023. Second, the device must not have undergone significant changes in its design and intended purpose.
 
The EU released the common specifications alongside an implementing regulation about reclassification of products without an intended medical purpose. The document reclassifies three sets of devices that MDR lists as products without an intended medical purpose. After the changes, high intensity electromagnetic radiation emitting equipment for skin treatment will be class IIa or IIb, equipment intended to be used to reduce, remove or destroy adipose tissue will be class IIb and equipment intended for brain stimulation that apply currents or fields to modify neuronal activity will be class III.
 
EU Regulation, More
 
European Commission outlines plan to develop emergency regulatory pathways for diagnostics
 
The European Commission plans to explore and develop regulatory pathways for diagnostics “to ensure both an appropriate level of control and speedy access to the market in the event of an emergency.”
 
Writing in its State of Health Preparedness Report, the Commission’s Health Emergency Preparedness and Response Authority (HERA) identifies diagnostics as essential medical countermeasures, in terms of both their role in epidemiological surveillance and the identification of the most suitable treatment. As HERA notes, diagnostics enable pathogen identification and antimicrobial susceptibility testing.
 
Learning from the lessons of the COVID-19 pandemic, the Commission plans to identify new regulatory pathways as part of the joint implementation and preparedness plan for the In Vitro Diagnostic Regulation.
 
HERA outlined the plan in a document that touched on all aspects of preparedness. Another section of the text described how the new clinical trial regulations will “facilitate, streamline, speed up and increase transparency for multinational” studies of therapeutics and vaccines.
 
The publication of the report coincided with news of an agreement between HERA and the World Health Organization (WHO) Hub for Pandemic and Epidemic Intelligence. HERA and WHO Hub will strengthen cooperation on countermeasures to prevent, prepare, detect and rapidly respond to serious cross-border threats to health.
 
Each party will involve the other “when developing work plans and research roadmaps, to better consider the respective agendas and overall research and development of advanced medical countermeasures and related technologies.”
 
EU Report, More
 
EMA’s Emergency Task Force supports use of BA.4/5 vaccines for primary vaccinations
 
EMA’s Emergency Task Force (ETF) has backed the use of bivalent mRNA vaccines that target the original SARS-CoV-2 strain and omicron BA.4/5 subvariants for primary vaccination courses.
 
Pfizer-BioNTech and Moderna received European authorization for such bivalent mRNA vaccines for use as boosters in people who previously received a first-generation vaccine such as the original Comirnaty and Spikevax as their primary course. After assessing the evidence, ETF has concluded that the bivalent vaccines may also be used for primary vaccination.
 
ETF reached the decision after reviewing the results of laboratory studies and data on the immune responses of unvaccinated people, who had not previously had COVID-19, to natural infection with the BA.4 or BA.5 subvariants of omicron.
 
“The data suggest that primary vaccination with these adapted bivalent vaccines should give rise to a broad immune response in people who have not yet been exposed to, or vaccinated against, SARS-CoV-2,” EMA wrote. “The ETF further noted that the safety profile of the adapted vaccines when used as boosters is comparable to that of the original mRNA vaccines, for which the safety profile is well established.”
 
The ruling means national authorities can use the bivalent vaccines for primary vaccination, if needed. Most, 73%, of people in the EU have already completed their primary course. Uptake has barely increased this year.
 
EMA Notice
 
MHRA moves medical device adverse incident reporting to new MORE portal
 
The UK Medicines and Healthcare products Regulatory Agency (MHRA) is asking device manufacturers, responsible persons and authorized representatives to use its new MORE portal to file adverse incident reports.
 
Until recently, MHRA accepted reports via its MORE system and through emailed submission of an XML output of the Manufacturer Incident Report form. MHRA planned to remove the XML email option on 21 November, thereby restricting submissions to its MORE portal or via its “custom application programming interface (API) for direct submission from your internal systems.”
 
The agency provided an update at the start of the week. MHRA’s guidance now states manufacturers can report adverse incidents for devices via the MORE portal, but that they can also continue using the XML email option until April. That section of the guidance no longer refers to the custom API, although elsewhere in the text MHRA still asks people interested in setting up an API to contact its team.
 
MHRA Guidance

 

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