Anticipate changes in standards and regulations applicable to your medical devices
The medical device and in vitro diagnostic medical device sectors operate within a demanding regulatory and standards environment. Manufacturers, distributors, importers, authorized representatives, and subcontractors must be able to identify the laws, standards, guidelines, and recommendations applicable to their products and then assess their impact on their organization, technical documentation, and quality management system.
Isocèle Conseil offers a regulatory and standards monitoring service tailored to medical devices and in vitro diagnostic medical devices, customized to your products, markets, and regulatory environment.
Why Set Up a Regulatory Monitoring System?
Effective regulatory monitoring makes it possible to:
- Maintain regulatory compliance for your medical devices;
- Anticipate changes to CE marking;
- Update your technical documentation;
- Adapt your quality management system;
- Plan corrective actions;
- Prepare for your notified body’s audits;
- Ensure the successful commercialization of your devices.
Our Support
Monitoring based on your reference framework
Our service begins with an assessment of your products, your operations, the countries where you sell your products, and your regulatory environment.
Based on this, we establish a dedicated regulatory and standards framework to identify the laws, standards, guidelines, and requirements applicable to your devices.
Once this framework has been approved, Isocèle Conseil establishes a regular monitoring process to track developments that could impact your products, processes, or regulatory obligations.
Monitored sources
Monitoring may focus, in particular, on:
- the standards applicable to medical devices and in vitro diagnostic medical devices;
- draft standards and new ISO publications;
- European regulations, decisions, communications, and guidelines relating to medical devices and DMDIVs;
- the MDCG guidelines published by the European Commission;
- harmonized standards published in the Official Journal of the European Union;
- French regulations applicable to medical devices;
- publications in the Official Journal: laws, decrees, orders, decisions, notices, and texts relating to medical devices, DMDIVs, or their potential coverage by the Health Insurance system;
- ANSM publications: regulatory information, vigilance, traceability, information bulletins, recommendations, recalls, or safety information;
- the applicable regulations and guidelines in the countries where your devices are marketed.
Analysis and reporting of identified trends
Each new standard, guideline, or regulatory document identified within the scope of our monitoring is analyzed to determine its relevance and potential impact on your organization.
When a change is implemented or is likely to have an impact, we do the following:
- updating the regulatory and standards framework;
- preparing a summary report that includes the context and analysis of the text;
The goal is not just to identify new publications, but to provide you with actionable information tailored to your business.
Terms of Service
This service is offered as an annual package.
The scope of the monitoring, the frequency of reporting, the format of the deliverables, and the countries covered are defined in consultation with you based on your needs, your products, and your internal constraints.
Frequently Asked Questions About Monitoring
Yes. Manufacturers must identify and take into account the regulatory requirements applicable to their medical devices throughout their lifecycle. Regulatory and standards monitoring is an essential means of maintaining compliance for products, their technical documentation, and the quality management system.
The frequency is determined based on your needs and the scope of the service. Depending on your business, a monthly or quarterly monitoring service can be set up to ensure regular tracking of regulatory and standards changes.
Each significant change identified is documented in a summary sheet that outlines the context, key requirements, effective dates, and affected systems, along with an analysis of its potential impact on your organization, your technical documentation, or your quality system.
Yes. Depending on your needs, we can include regulatory requirements applicable to other markets within the scope of our monitoring, including the United States (FDA), Canada (Health Canada), the United Kingdom (MHRA), Switzerland (Swissmedic), or any other country where your devices are marketed.
Yes. Each service is fully customized. The scope of the monitoring service is defined based on your medical devices or DMDIVs (implants, electromedical devices, software, AI, etc.), your business activities, your markets, the relevant technologies, and the regulatory standards that apply to you.
Are you interested in setting up a regulatory and legislative monitoring system?
Isocèle Conseil assists you in developing your reference framework, monitoring relevant changes, and analyzing their impact on your procedures and quality system.
Contact us to determine the scope of monitoring that best suits your organization.