Regulatory watch consists in the activity related to keep under active monitoring all the standards and regulation applicable to your medical devices and to your quality management system, in order to properly identify new or updates regulations.

Every medical devices and every quality management system have specific applicable regulations that may differ based on different factors. Typically, the regulations and standards applicable to a device are dependent on the specific intended use of the device; at the same time, for the quality management system, the applicable regulations are based on the countries where the devices are sold. For example, if the medical devices are distributed in United States, 21 CFR 820, 803 and 806 are applicable to your quality management system processes (other parts of the Code of Federal Regulations may be applicable, for example 21 CFR part 11, related to the management of electronic systems and electronic signatures).

What is the Regulatory Watch in practice?

In the easiest approach, the regulatory watch is simply a list of standards and regulation applicable to your products and quality management system. Obviously, there are ISO standards that in any case may be applicable to your medical device, independently from the type of device. These standards are, for example:

• ISO 14971:2019 – Medical devices — Application of risk management to medical devices
• IEC 62366-1:2015 Medical devices – Part 1: Application of usability engineering to medical devices
• ISO 15223-1:2021 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements
• ISO 10993-1:2018 – Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

These are just examples, there might be much more applicable standards based on the specific characteristics and intended use of the medical device.

How to Keep the Regulatory Watch Updated

In the regulatory watch file, the following information should be recorded:

• Country of Applicability of the specific standard;
• Code of the Standard;
• Harmonized standard (Yes/No)
• Version (year)
• Date of Publication;
• Date of Application;
• Status of the standard In force/withdrawn/cancelled/project;
• Whether conformity to the standard is claimed or not. If no, a justification shall be provided;
• Description of the standard (title)
• For newly or revised regulatory standards, where actions to achieve compliance need to be implemented (Yes/No) and, in case, expected date of conformity and associated

The regulatory watch is based on different source of information; these sources of information shall also be used to monitor whether new or updates standards have been published or are currently under development.

The typical source of information to prepare the regulatory watch are:

Management of New or Updated Standards and Regulations

The introduction of a new applicable standards to the Quality System or to an existing products should be handled through a change control process. In this context, a gap analysis shall be performed, with the goal to properly identify the gaps that need to fulfil to reach compliance with the new or updates standards or regulations.

Obviously, in the change control plan, an appropriate evaluation of the impact of this change shall be adequately documented.

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The regulatory watch contains three different pages. A first page contains the list of regulatory standard, the second one the list of legal

requirement. The third page (New Legal/Regulatory Requirements) contains the list of newly legal or regulatory requirements which have been

recently published; for each of these new requirements, as mentioned afore, expected date of conformity and evidence of compliance shall be

included.

When documented evidence of the actions needed to achieve compliance has been included, the new requirements is transferred to the first or

second page of the Regulatory Watch, as in this situation Dreem is claiming compliance to the specific standard.

The necessity to update the regulatory watch is evaluated during management review