Important Players in Medical Device and Drug Regulation Case Study - Nursing Assignment Help

Assignment Task

Task
1. Describe the functions of the following important players in medical device and drug regulation:
HPRA (Health Products Regulatory Authority)
HPRA is responsible for drugs, medical devices, clinical trials, and other health product regulation on the Irish market ("Regulatory Information" 2022).Medical device: The HPRA has divided medical devices into three separate groups, general, active implantable, and in vitro diagnostic medical devices. Each group represents medical devices with differing risk-levels whichrange from low to high risk. The HPRA provides support to medical device innovation. The HDPR can allow individuals to apply for a clinical investigation into a device. A clinical investigation is performed by one or more human subjects to assess the performance and safety of a medical device. The HPRA also conducts preliminary meetings with the device developers which give an overview into the regulatory requirements that the device must meet in development. This ensures that the product is developed to the safety standard of the HPRA ("Clinical Investigations" 2022).The HPRA also carries out remote inspections and distant assessments due to COVID-19 restrictions. These inspections follow a similar format as in-person inspections. They consist of an opening and closing meeting via video conference. Audits are regularly carried out on the medical device manufacturers. These audits are conducted to ensure that the medical devices are complying with the medical device directive’s schedule and statutory instruments and the ‘essential requirements’. The HPRA is also involved in the surveillance of these medical devices to uncover any issues so they can highlight the priority areas in the medical device market ("Quality Auditing & Surveillance" 2022).
Drugs: the HPRA aims to ensure that the medicines are safe for use and do what they need to do.
A pharmaceutical company will apply for review by the HPRA which, after they do a review of a drug in terms of its safety, effectiveness and quality, they give out licences to these medicines. Even after a drug has been approved and is used by the public, the HPRA continues to monitor its safety, effectiveness, and quality.HPRA encourages communication of side-effects and any other issues that may relate to a drug through their website and then share this information with the public if appropriate. If there is a concern relating to a drugs quality or safety, the HPRA carries out a range of regulatory actions such as changing the information of the drug, the safety notices, recalls, or suspensions of the drug.The HPRA then carries out an investigation onsite to make sure there is legislation and standard compliance in the drug production. Wholesalers and manufacturers are then regularly audited.
The marketplace is also monitored for any possible counterfeit products which could possible be health risks for individuals.Finally, the HPRA keeps a record of the drugs that are permitted from use in Ireland ("Our Role HPRA" 2022)
FDA
They have four primary functions in the regulation of drugs and medical devices:

• New product review
• Research and enforcement
• Monitoring marketed products

Developing and implementing the regulations and standards
The FDA is an agency located in the USA. This body regulates and supervises the safety and efficacy of food, drugs, biological products, cosmetics, radiation products and medical devices for the public’s protection. They establish and enforce product standards, regulations, and guidance document that supports the FDC act. Worldwide, there are regulations which govern product approval, however there are additional requirements for specific devices which are outlined by the FDA in the USA. For example, the FDA requires medical device manufacturing companies to follow the current ‘Good manufacturing properties’. There are over 1,200 of these standards recognised by the FDA.The FDA reviews and approves of pre-marketing submissions of medical devices and drugs.The FDA advances public health by speeding up the innovations of medicines to make them safer, more effective, and more affordable. The FDA speeds up innovations which allow for the improved safety, efficacy and affordability and aid the public access scientifically accurate information for the safe use of food and medicines which in turn, protects public health.Products and facilities are inspected and if necessary, follow-up enforcement actions are carried out.The manufacturing, marketing and distribution of tobacco products are monitored by the FDA which reduces the number of minors consuming tobacco.Counterterrorism capability: natural and deliberate emerging public health threats are monitored and responded to by making sure food supply security is monitored and fostering medical product developmentThe labels, information provided, packaging, advertising, marketing is ensured to be truthful and accurate and not misleading to the public Competent Authorities
These authorities have roles in administrating regulations at a national level.
In Ireland, the health products regulatory authority (HPRA) as mentioned covers medical devices and drugs. This used to be known as Irish medicines board.
The roles that these authorities are responsible for include:
Approve of drug marketing authorisation applications which are made directly to the national authority or indirectly through the EMEA.Monitor and approve of information which is displayed on leaflets and other promotional material on the drugs and medical devices to prevent false or misleading information being exposed to the public.Carry out the licensing of inspection/drugs and facility licencingClinical trials and operations of market vigilance systems are approved and licensed by these competent authorities on a national scale.
 

Notified Bodies

• This is an organisation in the EU which has been appointed to assess and regulate certain products. Rather than being a statutory body, they are organisations that carry out inspection and auditing. The roles of a notified body include the conformity assessment of products under the relevant EU directives and regulations. This assessment usually includes an audit of the manufacturers quality system ("Approved bodies for medical devices" 2022).
• Examination: pre-market authorisation is needed for a product. Independent experts are required to give their opinion to the notified body on high-risk products prior to a final decision on certification is made
• Enforcing regulation: they do this through unannounced audits of manufacturing processes. The manufacturing quality processes are evaluated (Kube et al. 2022).
   

EMA (European medicines agency)

• This is the second body with a pan-European regulatory remit. The EMA has functions in the regulation of medical devices and drugs including:
• They allow for the timely access to new medicines and have an important role in supporting the development of medicine for patient benefit: For this, regulatory mechanisms are carried out to achieve this. These mechanisms are continuously reviewed ("What we do - European Medicines Agency" 2022).
• They evaluate applications for marketing authorisation: Based on scientific evaluation of data, they produce independent recommendations on medicines for veterinary and human use. They also oversee decisions on European marketed medicines. They also continuously monitor the safety of medicines that have been EU authorised. They publish clear information about medicines ("What we do - European Medicines Agency" 2022).
• Continuously evaluate the safety and security of medicines in the EU: This ensures that these medicines have more benefits than risks. To do this, they make guidelines and set standards for the drugs. They make sure that the pharmaceutical companies are complying with these guidelines and standards. They contribute to international pharmacovigilance activities. Lastly, they make sure the public is informed about the drug and external party’s safety ("What we do - European Medicines Agency" 2022).
• Provide information to patients and healthcare professionals: impartial and clear information and approved uses regarding the drug is published by the agency ("What we do - European Medicines Agency" 2022).
• Part 2: 12% (30% of marks out of 100%)
• 2. Using the FDA medical device classification database -pick a device and show with screenshots its product code and classification etc. (read classification notes attached on blackboard for guidance). Justify why your device is a class I, II or III device.
• Breast implants are a class III medical device. The reasoning as to why these devices are associated with class III risk, is that there is a high chance of risks and complications which increase the health risk to the patient.
   

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