Excluding the United States, European recommendations for medical device manufacturers are important and globally influential factors. Businesses seeking to distribute products in international markets will benefit from a thorough understanding of EU regulations and standards.
In Europe, the primary sources of medical device standards are the International Organization for Standards (ISO) and the International Electrotechnical Commission (IEC). The ISO and IEC issue international standards which potentially apply everywhere. However, they must be accepted and adopted in whole or part by the governments of the world for legal effect within their respective borders.
Medical devices must have certified approvals from the nations in which they may be sold. This discussion of GxP for medical devices must begin with the U.S. and Europe.
Among the EU Nations, medical device approvals involve the EU CE marking; in the US, medical device approval requires an FDA certification. The FDA in 21 CFR 800 series of regulations, the EU Guidelines, and European Regulatory Authorities play dominant roles in the governance of medical device development and manufacture. In a recent analysis, we compared the quality system requirements of ISO 13485:2003 with 21 CFR 820.
The European Union Standards
The EU was a pioneer in medical device governance groups. Its standards have been global benchmarks used by many nations.
CEN is the European Committee for Standardization and is the governance equivalent of the ISO. The European Committee for Electrotechnical Standardization is called CENELEC. It is similar to the IEC.
The CEN nominates its standards with the prefix EN; thus, upon adoption, ISO 13485 becomes EN ISO13485:2012, Medical devices — Quality management systems — Requirements for regulatory purposes.
International Good Governance and Harmonization
The World Health Organization played an important initial role in gathering major governments into a coalition for the purpose of creating common standards for medical devices. The Global Harmonization Task Force came into being as a result of the WHO impetus, and it achieved the primary levels of standardization and manufacturing practices.
There are several ongoing initiatives and organizations that promote increased harmonization on medical device certifications and quality assurances. Building on the work of the Global Harmonization Task Force on Medical Devices (GHTF), the International Medical Device Regulators Forum is a public body dedicated to promoting and accelerating regulatory harmonization on a global basis.
The membership of the forum includes regulators from the leading economies and representing every continent.
The Nominal Structure of International Standards
It is useful to note the structure of international standards. The descriptive title and series number advises the source, date, and subject. These are important factors when citing and using these authorities as well as reflecting their scope.
The first part is the issuer, and in this example it is the ISO. The second part is in the assigned document number, 13485. The third part after a colon is the year of issuance.
All of these elements are necessary to identify a standard properly. When adopted or incorporated into the laws and regulations of a member nation, the code changes by adding prefixes. For example, as adopted in Ireland, the ISO issued from the National Standards Authority of Ireland as I.S. EN ISO 13485:2012.
International Standards and Rulemaking
ISO 13485:2003, Medical devices — Quality management systems — Requirements for regulatory purposes is the international standard for quality management in medical device manufacturing. The comparable U.S. regulatory document is the FDA regulation 21 CFR 820.
The ISO 13485 standard was issued in 2003. It was adopted by ANSI and AAMI, U.S.-based standards organizations. The FDA does not accept ISO 13485. It issued rules pursuant to 21 CFR 820 for a different set of quality management system procedures. However, when manufacturing drugs or medical devices for international distribution, the principles of the international standards will guide a successful process.
The Challenge of Non-US Regulations
Harmonization and standardization efforts will continue to reduce procedural duplication and avoidable differences among the world’s markets. The safety and efficacy of medical devices is a common objective.
In the interim, manufacturers must build general principles into their quality management systems and work through individual national requirements. Presently, national requirements vary from virtually nothing to strict compliance with unique requirements, including language and customs.
When providing medical devices in foreign markets, get the detailed and in-depth assistance needed to succeed. GxP-CC provides comprehensive compliance strategies and step-by-step assistance to bring a medical device to foreign markets.