The text of the proposal discusses some of the high-level themes of what both sides would to like find more common ground on, including the convergence of technical and clinical requirements applicable to devices; removing unnecessary duplications of data submission and device testing and to avoid duplicative inspections of manufacturing sites; to promote the convergence of device standards; and to promote existing multilateral and bilateral regulatory cooperation related to devices.
In addition to recognizing the importance of collaborating as part of other device-related international organizations – like the International Medical Devices Regulators Forum (IMDRF), the International Organisation for Standardisation (ISO), the International Electrotechnical Commission (IEC) and the Global Medical Device Nomenclature (GMDN) – the text focuses on:
- Quality management system audits
- Unique device identifiers (UDIs)
- Data submission
- Cooperating on exchanging information on noncompliant devices
- Cooperation on device standards
- Further exchange of regulatory information among regulators
A number of the details offered focus on consistency and collaboration via IMDRF. For instance, in order to ensure the interoperability of UDI databases, the text calls on both US and EU regulators to develop their databases in line with the guidance adopted by IMDRF.
“For that purpose, each Party shall promote the use of a common format for data exchange between unique device identification databases, and take into account relevant specifications and semantic standards existing in the area,” the text reads.
The proposal also focuses on ensuring that US and EU authorities can exchange regulatory information, including confidential and trade secret information related to conformity assessment, approval and the supervision of devices, though it also says neither side will publicly disclose such confidential information of commercial, technical or scientific nature, including trade secrets not in the public domain.
“The regulatory cooperation between the responsible authorities of the Parties shall be guided by a joint regulatory cooperation work plan which sets out short and medium term priorities for regulatory cooperation under this Annex,” the text adds.
The proposal on devices comes two months after a similar proposal around convergence of EU and US pharmaceutical regulations.
EU PROPOSAL FOR AN ANNEX ON MEDICAL DEVICES