IVDR 2017/746is live now. An IVDR came in force on 26 may 2022, the previous directive 98/79/EC(IVDD) is replacedRegulation (EU) 2017/746 on in vitro diagnostic medical devices.let’s understand the impact exactly. IVDR is effective now; Class A non-sterile devices are self –declared, they must meet EU-IVDR requirement. All new devices or existing devices should undergo the significant change and they should meet IVDR from 26 May 2022.
MDCG2022-8 regulation(EU) 2017/746 explains the application of IVDR requirement to legacy devices. Legacy device means the devices those already in the market prior to the new regulations, According to the article 110(3)of the IVDR, legacy devices can be covered by valid EC certificate issued by notified body in accordance with IVDD prior to 26 May 2022. If you are launching new product in EU market after 26May 2022, then it will not be a legacy device. The implementation of EUIVDR 2017/746 from 26 May 2022,will vary as per the classification of the device.
为新分类设备交接日期as per IVDR who require the involvement of notified body are:
- Class D- 26 May,2025
- Class C-26 May 2026
- Class B-26 May2027
- Class A sterile -26 May 2027
Let’s understand the transition period. Let’s say you have legacy device and its of Class D then the product will be in the market till 26May2025 under the directives 98/79/EC. In this transition period manufacturer need to plan a strategy to obtain the certification from Notified body to continue under IVDR, however the challenge is there are few notified bodies at present and they will be overloaded soon.
From 26 may 2022 device must have updated QMS to meet the IVDR , need to update design control ,significant changes according MDCG2022-06 in change control process, post market requirement including PMS report, PMS plan , formally appoint PRRC before placing the first product to the market under IVDR. In addition to this Class A non- sterile devices should have full technical file & declaration of conformity to IVDR.
Many manufacturers may have well- filled warehouses and they might be in worry how to deal with it? let me tell you that the manufacturer needs to examine few approaches like relabelling of existing goods, placing on the market before deadline not just from the perspective of IVDR but in regard to contract law and regulations. If you have not compliant with the legislation after the transition period, your product can’t be placed on market after due date.
If you want to understand the concept of placing on the market and want to find out ways to deal with new regulations you can contact us . AsCE mark medical device consultantwe can help you in placing your product in EU market. Weare medical device regulatory consultantwho can guide you about the new regulations. If you want read more medical device regulatory updates kindly subscribe ourNewsletter!
References :–https://ec.europa.eu/health/system/files/2022-05/mdcg_2022-8_en.pdf
