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As technology in life sciences races ahead – and regulation races to keep up – it takes expert legal advice to steer both large and small organisations in this space.
FREMONT, CA: The life science industry needs to be more focused on having a strong legal and compliance framework, establishing important contractual partnerships, and scaling up the business. Legal support, on the other hand, becomes more specialised and adapted to the many business divisions, such as R&D, market access, medical affairs, commercial operations, corporate administration, etc., for mature organisations. It is intriguing and engaging to mix with highly educated individuals and frequently pioneering scientists. Additionally, as the relevant industry is frequently global, lawyers must expand their knowledge and networks abroad. Fortunately, there are standardised rules in many industries now, and technological advancements have helped to remove further hurdles like language and distance.
The field of life sciences is governed at the EU level by several sectoral rules. The Medical Devices and In Vitro Diagnostics Regulations, the Clinical Trials Regulation, and the Medicinal Products Directive are only a few of the most relevant ones. Additionally, certain pieces of horizontal legislation, such as the GDPR, the Product Liability Directive, anti-competition and transparency rules, as well as the artificial intelligence legislation that will be developed in the upcoming years, are especially pertinent for businesses operating in the healthcare sector. The numerous soft laws and codes of conduct that may establish, if not requirements, then at the very least best practices to follow to uphold high ethical standards and to safeguard their reputation should also be known to businesses.
Across Europe, there is a general trend toward promoting harmonisation by switching to the legal instrument known as the Regulation, which, unlike the Directive, is instantly enforceable in its current form. For instance, in vitro diagnostics and medical devices now adhere to the same regulations across the EU/EEA. A qualified notified organisation appointed at the national level must conduct a conformity assessment on each medical device to confirm that it complies
with the Regulation's specifications. In specific circumstances, the EMA at the EU level should first publish a scientific opinion. Depending on how the medical device's unique risk is classified, other laws and requirements also apply. Manufacturers were required to provide clinical safety data, and the new laws generally created stricter procedures for conformity assessments and post-marketing surveillance. This has a specific influence on medical gadgets such as apps and software. Depending on how the medical device's unique risk is classified, other laws and requirements also apply. Manufacturers were required to provide clinical safety data, and the new laws generally created stricter procedures for conformity assessments and post-marketing surveillance. This has a specific influence on medical gadgets such as apps and software.
The accreditation and classification of a piece of software as a medical device are currently heated challenges. The manufacturer's intended purpose description is crucial in achieving this. In theory, any software that is designed with the intent to process, analyse, create, or modify medical information must be certified as a medical device. One must keep in mind that the maker assigns a product's purpose not only through the label, the usage instructions, and the clinical evaluation but also through any comments made in promotional or sales materials. All regulatory standards must be met before software or an app may be considered a medical device. This means that any claims made about the intended medical use of the product must also be backed up by scientific data.
After a protracted wait, the centralised Clinical Trials Information System (CTIS) became operational on January 31, 2022, and the Clinical Trials Regulation, which repealed the prior Directive of 2001, went into effect in the EU/EEA. Clinical trial sponsors formerly had to send their applications to national competent authorities and ethical committees individually to obtain regulatory approval. Now, sponsors can use the CTIS to submit a single online application to conduct a clinical trial in as many as 30 European nations.