Drugdu.com expert’s response: The 4-digit number next to the CE mark on medical devices indicates the Notified Body identification number (or Module D number). These digits identify the Notified Body that has certified the device’s quality management system. It signifies the registration number of the certifying body, indicating that it has assessed the quality management system of the medical device and confirmed its compliance with the relevant European Union directive requirements. This number is crucial for tracking the validity of the certification and for regulatory purposes.
The sandbox will help to inform future AI Airlock projects and influence future AlaMD guidance The Medicines and Healthcare products Regulatory Agency (MHRA) has launched AI Airlock, a new regulatory sandbox, to address the challenges of regulating medical devices that use artificial intelligence (AI). In alignment with the regulator’s goal for the UK to be a science and technology superpower by 2030, the new sandbox builds on the MHRA’s strategic approach to AI in April, which was set out to respond to a white paper published by the government in 2023. It highlighted that the regulator is considering the opportunities and risks of AI from three perspectives: as a regulator of AI products, as a public service organisation delivering time-critical decisions and as an organisation that produces evidence-based decisions that impact public and patient safety, where evidence is often supplied by third parties. The new sandbox for AI as a ...
Dive Brief The Food and Drug Administration published final guidance on the remanufacturing of medical devices on Thursday. Acting on feedback from groups including Advamed, the FDA has changed the title of the text and added a section on the regulatory requirements for remanufacturers. The new section, which applies to original equipment manufacturers and service providers, is intended to help entities that are less familiar with the medical device regulatory requirements. Dive Insight The FDA published draft guidance in 2021 to clarify the distinction between device remanufacturing and servicing. Many reusable medical devices are serviced. Previously, it was unclear when servicing became so extensive that it qualified as remanufacturing. The draft defined remanufacturing as an act done to a finished device that significantly changes the performance, safety or intended use, including renovating, repackaging or restoring products. After assessing feedback on the draft, the FDA has retained its definition of remanufacturing ...
Drugdu.com expert’s response: Corrective and Preventive Actions (CAPA) in medical devices refer to a series of measures taken in response to identified issues or defects. CAPA aims to ensure the safety and effectiveness of medical devices and compliance with regulatory requirements. These measures include: 1.Corrective Actions: Steps taken to address existing issues or defects, aimed at eliminating or correcting their root causes to prevent recurrence. This may involve repairs, improvements to product design, or enhancements to manufacturing processes. 2.Preventive Actions: Measures taken to address potential issues or defects, intended to prevent future quality problems. This may include improving product design, updating manufacturing processes, or enhancing training. CAPA is an essential component of the quality management system for medical devices, often detailed in standards such as ISO 13485. Implementing CAPA helps ensure the safety, effectiveness, and quality of medical devices, while also ensuring compliance with regulatory requirements.
Drugdu.com expert’s response: The relationship between FDA registration and 510(k) clearance for medical devices involves overlap but also key distinctions. Relationship: 1.FDA Registration: This encompasses the process of submitting product information to the U.S. Food and Drug Administration (FDA) and obtaining FDA approval. It includes various types of registrations, such as 510(k) clearance, Premarket Approval (PMA), among others. 2.510(k) Clearance: This is a specific certification process within FDA’s regulatory framework, typically applicable to certain medical devices for which there are similar existing products on the market. In the 510(k) clearance process, manufacturers need to demonstrate that their product is substantially equivalent to an existing marketed device and does not pose an unreasonable risk to the user. Differences: 1.FDA registration is a broader concept encompassing various registration pathways, of which 510(k) clearance is one. 2.Within FDA registration, if a medical device can demonstrate substantial equivalence to a predicate device and meets ...
Drugdu.com expert’s response: The specific process of CE certification for medical devices typically includes the following steps: 1.Preparation of Application: Manufacturers first need to prepare comprehensive application materials, including technical documentation, product specifications, quality management system documents, etc. 2.Selection of Certification Body: Choose an appropriate certification body for CE certification, ensuring that it is accredited and recognized. 3.Evaluation and Testing: The certification body will conduct evaluation and testing of the product to ensure compliance with the relevant European Union Medical Device Directives. 4.Compilation of Technical Documentation: Manufacturers need to compile complete technical documentation, including product descriptions, design files, test reports, etc. 5.Conducting Audit: The certification body will audit the manufacturer’s technical documentation to ensure its completeness and compliance with requirements. 6.Issuance of Certificate: If the product passes the audit and meets the requirements, the certification body will issue a CE certification certificate, confirming that the product complies with relevant standards ...
Drugdu.com expert’s response: To sell Class I medical devices, you typically need to obtain the following qualifications: Medical Device Operation License: According to the “Regulations on the Supervision and Administration of Medical Devices,” any unit or individual engaged in activities such as production, operation, use, or technical services of medical devices must obtain a medical device operation license to operate medical devices. Business License: As a business entity, you need to have a valid business license to engage in legal business activities. Other Relevant Qualifications: Depending on the specific situation and requirements, you may also need to obtain other relevant qualifications such as medical device registration certificate, production license, etc.
Dive Brief Renovo received a warning letter in October for supplying reprocessed medical devices without seeking 510(k) clearance from the Food and Drug Administration. The letter, which the FDA published Tuesday, accuses Renovo of providing reprocessed models other than the ones covered by its 510(k) clearances. Renovo failed to evaluate how cleaning and re-sterilization of the additional models could affect performance and reliability. FDA inspectors also identified problems with Renovo’s approach to air particulate sampling that prompted warnings about the failure to establish control procedures. Dive Insight Renovo cleans medical devices that have been used in procedures such as the ablation of soft tissue for reuse. Renovo has multiple 510(k) clearances that permit the company to supply reprocessed versions of devices such as Depuy Mitek Ablation Wands and Ethicon Bladeless Trocars. The problem, according to the FDA, is that Renovo has reprocessed models that are outside of the scope of ...
The government has today announced action to tackle potential bias in the design and use of medical devices, as it accepts recommendations from a UK-first independent review. The Department of Health and Social Care commissioned senior health experts to identify potential biases in these devices and recommend how to tackle them. The government fully accepted the report’s conclusions and has made a series of commitments, including ensuring that pulse oximeter devices used in the NHS can be used safely across a range of skin tones, and removing racial bias from data sets used in clinical studies. Minister of State, Andrew Stephenson said: I am hugely grateful to Professor Dame Margaret Whitehead for carrying out this important review. Making sure the healthcare system works for everyone, regardless of ethnicity, is paramount to our values as a nation. It supports our wider work to create a fairer and simpler NHS. Ministers agree ...
Drugdu.com expert’s response: Medical devices are typically classified into different categories, including Class I, Class II, and Class III, based on their level of risk and intended use. Here is a general overview of how these categories are distinguished: Class I Medical Devices: Class I medical devices are generally considered to have low risk and may have little or no impact on the human body. They typically do not require specialized regulatory controls.These devices include simple, non-invasive devices such as thermometers, disposable gloves, non-invasive blood pressure monitors, etc. Class II Medical Devices: Class II medical devices pose higher risks compared to Class I devices and may have a moderate impact on the human body, requiring stricter regulatory controls.Examples of Class II devices include diagnostic equipment, infusion pumps, medical imaging devices, implantable medical devices, etc. Class III Medical Devices: Class III medical devices carry the highest level of risk and may cause ...
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