Marketing a medical device in the EU requires the preparation of technical documents that demonstrate compliance with the Medical Device Directive (MDD), the Medical Device Regulation (MDR), and other requirements as well as the implementation of specified conformity assessments.
SunFlare provides prompt and reliable consulting services related to the acquisition of CE marking. These services range from identifying the basic requirements that are applicable to the client through to drafting technical files (Clinical Evaluation Reports, etc.).
Workflow for complying with the MDD and other regulations for European CE marking
We provide a range of services related to the conducting of clinical evaluations, from devising clinical evaluation strategies and conducting academic paper research to drafting clinical evaluation reports. In providing these services, we carry out the following steps:
Creating a new clinical evaluation plan (in compliance with MEDDEV 2.7/1 Rev.4)
Step 1: Analyze the product's future prospects and assess the evaluation methods
Hold lectures on the requirements for MEDDEV 2.7/1 Rev. 4
Check the current risk management, non-clinical evaluations, and related documentation
Investigate equivalent products and verify their equivalence
Conduct a preliminary literature investigation to identify core clinical data
Draft a plan, if feasible, based on the above activities
Step 2: Draft documents related to the clinical evaluation
We assist in establishing a quality management system (QMS) that complies with the European Standard EN ISO 13485. As part of this assistance, we:
Analyze the client's existing QMS to determine whether it complies with the requirements of EN ISO 13485
Provide and customize samples of procedure manuals and forms related to acquiring CE marking, conducting clinical evaluations, preparing technical documents, and ensuring vigilance compliance with European standards
In some ASEAN countries, obtaining CE marking for a product can simplify the examination process and provide a partial exemption for the document submission requirements. Therefore, obtaining CE marking facilitates access not only to the EU but also to the ASEAN market.
Drafted by the European Commission in 2012, the Medical Device Regulation (MDR) was adopted on April 5, 2017, to replace the Medical Device Directive (MDD) as the EU's regulatory framework for medical devices. This regulation was officially enacted on May 26, 2017. For details,please see the MEDTEC WEB website (in Japanese). SunFlare's monthly e-mail magazine on medical devices also provides information on the latest trends related to the MDR, other laws and regulations in various countries, and revisions to standards. This e-mail magazine is available only in Japanese. To subscribe, please fill out the registration form.