Over the past few months, through the Thema HelpDesk service, we have received numerous questions regarding the international regulation of Medical Devices. Indeed, Thema’s customers are increasingly involved or interested in expanding their business in non-European countries, facing the regulatory challenges of new markets with our help.
Regulations governing the IVD sector vary widely depending on the local jurisdiction. Therefore, manufacturers and distributors must understand the specific requirements for each market in which they operate or intend to operate.
In this article, we share a selection of questions received and answers provided through our Help Desk, a service that offers quick information on all Quality and Regulatory Affairs issues in the medical sector.
What are the terms set by the UK regulatory authority MHRA for the mandatory adoption of the UKCA mark?
The UK authority will continue to recognise the European CE marking in the UK, until the period between 2028 and 2030, depending on the type of CE marking. Subsequently, manufacturers will have to obtain the UKCA mark to market in the UK. In Great Britain, a transitional period allows companies to market CE-marked devices:
- for MDR/IVDR/IVDD CE marked devices: until the CE certificate expires; or until June 30, 2030, whichever comes first;
- for CE MDD/AIMDD-marked devices: until the certificate expires; or until June 30, 2028, whichever comes first.
Current UK legislation on Medical Devices and IVDs is based on the old EU directives.
Substantial regulation is due to come into force in the UK in July 2025, after which all companies involved shall have the UKCA mark to continue marketing in the UK.
Is there a transition period for implementing Ministerial Decree No. 13 of 2022 in Kuwait?
Decree No. 13 of 2022 has been in force since January 23, 2022, and applies to all devices that fall under the definition of ‘medical device’. There is no transitional period for its implementation.
According to the definitions provided by the MDR Regulation (EU) 2017/745, what regulatory requirements must a ‘system’ fulfil to be considered as such?
According to MDR (EU) 2017/745, a system is defined as a combination of products, packaged together or separately, intended to be interconnected or combined to achieve a specific medical purpose.
Is a self-declaration by the manufacturer sufficient to market a radiofrequency-free aesthetic device in China, or are other certifications required?
To determine the regulatory route to follow to place an aesthetic device on the Chinese market, it must be verified that it meets the definition of a medical device according to Chinese regulations (Regulations on the Supervision and Administration of Medical Devices).
If it is not a medical device, CCC certification may be required, depending on the type of product. If it can be considered a medical device, a notification or registration procedure with NMPA will be required, depending on the risk class, and the manufacturer’s self-declaration will not be sufficient.
Are there Health Canada’s regulatory requirements for post-market surveillance and post-market clinical follow-up comparable to those in the European Regulation?
Health Canada’s Post-Market Surveillance (PMS) requirements are substantially different from those of the European Union and regulated according to MDR (EU) 2017/745. Specifically, there is no reference to the obligation to draw up PMSPs, PMSRs and PMCFs; however, the preparation of a Summary Report is required for class II, II and IV Medical Devices (Canadian risk classes); it is not required for class I MDs (sections 61.4 to 61.6). The Canadian Summary Report can be compared to the European PSUR
International regulations on Medical Devices are constantly evolving. The Help Desk service can help you stay up-to-date on the specific requirements of each market, which is essential to ensure the compliance and safety of products placed on the market.
Do you have a question? Do not hesitate to contact us.
