Euro Roundup: MHRA seeks feedback on in-house manufacturing exemptions for medical devices
The UK Medicines and Healthcare products Regulatory Agency (MHRA) is holding a consultation on a policy that exempts medical devices made, used, or modified by health institutions from certain requirements.Exempted devices do not need to meet the requirements of the Medical Devices Regulations 2002. With the UK changing its medtech regulatory framework, MHRA wants to refine the policy, also known as the in-house manufacturing exemption, and provide updated guidance. The plan reflects the belief that changes can increase the impact of the policy.
“There are promising opportunities for this policy to evolve, such as enhancing access to innovative medical technologies closer to home, while ensuring robust safeguards for patients and public health initiatives,” MHRA said.
The agency raised the possibility of extending access by “enabling exempted devices to be used beyond health institutions, supporting care delivery deeper into communities and within people’s homes.” MHRA is also aiming to strengthen safety by “promoting enhanced post-market surveillance, governance and improving visibility of exempted devices.” The goal is to ensure continued safety and effectiveness.
Ahead of potential changes, the agency is seeking feedback to assess how the current policy is used. MHRA will use the input to inform consultations, guidance and regulatory updates that it is planning for the coming year.
The agency has used the consultation to ask whether a lack of clarity on the scope and requirements of the exemption is deterring use of the policy. MHRA also wants to know whether any organizations or departments are using the policy to make devices at an “industrial scale.”
Officials have introduced the term for the survey. MHRA defines industrial scale as “mass production or operation of medical devices, typically using machinery, automation, and standardized/repeatable processes.” The term implies that “a volume or intensity suitable for commercial or mass-market purposes, rather than for personal, or small-scale use to a targeted population,” the agency said.
Another set of questions covers the use of quality management systems at sites making devices under the exemption. MHRA also wants to know whether sites have ISO certifications and what records they keep documenting their manufacturing activities.
The consultation is open until 15 September
MHRA Consultation
Commission finds AI developers see regulatory complexity as a significant challenge
A European Commission survey has found that 62% of artificial intelligence (AI) developers believe the complexity of the regulatory approval process is a significant challenge to the deployment of their products.
The Commission contacted 435 developers for the survey, but only received 32 responses to its question about the regulatory approval process. Around half of the healthcare professionals and hospital representatives surveyed agreed that the complexity of the regulatory approval process is a significant challenge to AI deployment.
“The complex regulatory landscape and associated procedures ... can sometimes prolong the time it takes for AI tools to reach the market,” the Commission said. “This subsequently delays the deployment of AI-based medical devices into clinical practice and increases the cost of deploying the AI solution in Europe.”
The Commission listed clinical evaluations, risk management procedures, and postmarket surveillance as examples of procedures that can delay AI deployment. An AI developer from Israel told the Commission that AI solutions often cost less in the US, where regulatory approval processes are shorter than in the EU.
Officials gathered more information on the challenges created by regulations at a workshop. Regulatory experts told the Commission that the administrative burdens of regulatory compliance, coupled with the need for “extensive documentation,” may deter healthcare institutions from using AI. The Commission said the deterrent is particularly applicable to sites with limited resources or technical expertise.
Sites may need robust infrastructure, technical capacity, and interdisciplinary collaboration to meet AI’s post-market surveillance requirements. The Commission said such capabilities “are often challenging to maintain over time.”
AI Report
Swissmedic adopts EU requirements on medical device electronic instructions for use
The Swiss Agency for Therapeutic Products (Swissmedic) has adopted EU requirements on electronic instructions for use (eIFU) with immediate effect.
An implementing regulation on eIFU came into force in July in the EU. The regulation changed the rules on when medical device manufacturers can provide instructions in an electronic format. Products intended for use by lay people still need to come with paper instructions, but an extended set of devices and accessories provided to healthcare professionals can ship with eIFUs.
“Where devices are intended for professional users, the permissible scope for electronic instructions for use has been extended to all medical devices and their accessories as well as to products without an intended medical purpose listed in Annex XVI to [EU MDR] and legacy devices,” Swissmedic said.
Swissmedic’s previous policy on eIFU was aligned with a position the EU adopted in 2012. Because the EU has repealed its 2012 policy, Swissmedic has immediately changed its position on eIFU to reflect the revised European Union rules. The agency moved to the new policy without changing the Swiss Medical Devices Ordinance.
Swissmedic Notice
Swissmedic outlines obligations for system and procedure pack assembly and labeling
Swissmedic has published an information sheet about regulatory obligations for assembling and labeling systems and procedure packs.
The document is aimed at assemblers, authorized representatives and users of systems and procedure packs in Switzerland. Procedure packs are devices that are packaged together and sold for a specific medical purpose. Systems are combinations of devices, either packaged together or not, that are used together to achieve a specific medical purpose.
Swissmedic’s information sheet describes the obligations of people who assemble or sterilize systems or procedure packs. Assemblers must declare that they verified the mutual compatibility of the devices and that the device combination “was subject to appropriate methods of internal monitoring, verification and validation.”
Another section of the sheet explains that systems and procedure packs are treated as devices in their own right when they incorporate devices that lack CE marks. In that scenario, the system or procedure pack is subject to the conformity assessment procedure.
Swissmedic also addressed the need to designate a Swiss authorized representative, labeling rules, registration requirements and the reporting of safety incidents. Companies have three months to register with Swissmedic after putting a system or procedure pack on the market.
Swissmedic Notice
Other news
The World Health Organization (WHO) has designated MHRA as a Listed Authority. The WHO-Listed Authority (WLA) framework, which replaced the stringent regulatory authority system, is designed to support efficient resource use and accelerate access to quality-assured products. MHRA said WLA designation affirms its commitment to the highest international standards. MHRA Notice
Swissmedic has published information on drug-induced taste disorders. Highlighting pharmacovigilance reports, the agency said the disorders are reported for all medicinal product categories. The disorders are particularly common in people on antineoplastic and immunomodulating substances and systemic anti-infectives, Swissmedic said, and are caused by a range of mechanisms. Swissmedic Notice
MHRA is seeking feedback on the ICH M4Q(R2) guideline. The International Council for Harmonisation text is an update to 2002 guidelines that harmonized the format of quality information for in human medicine registration filings. The update is intended to make registration and lifecycle management more efficient and make use of digital technologies. The consultation closes on 26 October. MHRA Notice
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