Date of application : 05-26-2020, 3 years to comply.
Several possible cases :
- You have a CE mark obtained according to Directive 93/ 42/ EEC BEFORE the date of entry into force : it remains in conformity until the end date of your certificate.
- You have a CE mark obtained according to Directive 93/ 42/ EEC AFTER the date of entry into force : it remains compliant until the end of the CE certificate or at the most 4 years AFTER the date of application of the Regulation, in 2024. Attention, if a substantial modification is made, this certificate will no longer be valid.
Nevertheless, any DM with a CE mark obtained under Directive 93/ 42 /EEC and on the market after 05-26-2020 must comply with : the requirements of the Regulation on post-market surveillance, market surveillance, vigilance, to the registration of economic operators and devices :
- ITEC Services has a strong expertise in the development and conduct of post-market surveillance studies and the vigilance management of your devices
- These activities are tailor-made taking into account the characteristics of each device and the needs of each company
Our recommendations for these major regulatory changes :
- Do an audit of all your devices to assess the conformity of their current file with the Directive and develop your product strategy at 3 years :
- Special attention to devices that will change class such as spine implants, joint implants that will enter class III. Do not hesitate to ask us to set up clinical investigations to obtain your CE marking according to the Regulations or the implementation of post-market surveillance studies if your device is already on the market. ITEC Services has real expertise in orthopedic surgery with several investigations/ studies carried out and ongoing for medical devices.
- Anticipate now because the Notified Bodies should not be recertified until January 2019 (estimate : we will follow up regularly). In fact, there will be only one year left to perform the certification audits: you must therefore provide this short deadline in your action plan.
- Plan monitoring studies for all your devices in order to maintain their place in the market, in line with your 3-year product strategy.
May 26th, 2017 – May 26th, 2020 : 3 years to conduct clinical assessments and meet the 2017/745 requirements
- CAUTION : For Medical Device class modification, such as spine implants, compliance with the 2017/745 requirements is required. Ask us for a quote to conduct your retrospective/prospective studies.
May 26th, 2025 : from that date ALL EC certificates issued under 93/42 and 90/385 directives will be invalidated
- Plan immediately to comply with the 2017/745 Regulation requirements of Medical Device classes IIa, IIb and III, which, without being modified, have a derogation until Mai 26th, 2024 to stay on the market. Ask us for a quote to conduct your retrospective/prospective studies.