A regulatory approach tailored to your markets
Regulatory compliance is a critical step in bringing a medical device to market, both in Europe and internationally. Each market has its own requirements, procedures, classifications, and documentation expectations. The regulatory strategy must therefore be defined as early as possible, taking into account the device in question, its intended use, its risk level, the available data, and the target countries.
Depending on the target markets, these steps may include, among other things:
- The product’s regulatory classification;
- Determining the classification;
- Identification of the applicable requirements;
- Defining the conformity assessment strategy;
- The creation or review of technical documentation;
- Analysis of clinical or performance data;
- Preparing for interactions with authorities or evaluation agencies;
- The implementation of post-market requirements;
- Support through the entire process until marketing authorization is granted.
CE Marking (Europe)
The CE marking allows a medical device to be placed on the European market, provided that it demonstrates compliance with the applicable requirements of Regulation (EU) 2017/745 (MDR) on medical devices or Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices.
Technical documentation is one of the key elements in demonstrating compliance and is mandatory regardless of the device’s class. Depending on the device’s class, the conformity assessment may involve a notified body, a quality system audit, and a review of the technical documentation.
FDA 510(k) (U.S.)
To gain access to the U.S. market, certain medical devices must undergo a pre-market notification process known as 510(k). This procedure is intended to demonstrate that the device is substantially equivalent to a device legally marketed in the United States.
Preparing a 510(k) submission requires, among other things, identifying the appropriate predicate device, demonstrating substantial equivalence, organizing the technical information, and justifying the necessary testing—for example, regarding performance, biocompatibility, software, sterilization, electrical safety, or cybersecurity, depending on the device in question.
Certification in Canada
In Canada, medical devices are regulated by Health Canada. The applicable requirements depend, among other factors, on the device’s class. Class II, III, and IV devices must have a medical device license before they can be imported or sold in Canada.
Canadian regulatory approval generally involves a detailed analysis of the classification, the preparation of the required forms and information, the compilation of the licensing dossier, and—for applicable manufacturers—compliance with quality management system requirements, including MDSAP.
Approval in Australia
The marketing of medical devices in Australia is regulated by the Therapeutic Goods Administration (TGA). Access to the Australian market depends, in particular, on the product’s qualification, its classification, demonstration of compliance with the Essential Principles, the availability of evidence of conformity assessment, and the submission of an application for inclusion in the Australian Register of Therapeutic Goods (ARTG).
Other Export Approvals
Beyond Europe, the United States, and Canada, manufacturers may choose to target other markets: the United Kingdom, Switzerland, Brazil, Japan, the Middle East, Asia, Latin America, or Africa.
Each country has its own regulatory framework, with specific requirements regarding classification, technical documentation, local representatives, registration, labeling, certificates, legalization of documents, partial recognition of existing markings, or post-market requirements.
Isocèle Conseil assists you in analyzing applicable requirements and coordinating export certification processes, in line with your priority markets and your business strategy.