An extended timeframe is suggested in the position paper from the EUMDCG to allow some legacy devices that have received MDD or AIMDD certification to comply with MDR.
EU MDCG 2022-18 issued ““MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate,” .The position paper, EU MDCG 2022-18, clarifies Article 70(1) MDR, which enables manufacturers and European Authorized Representatives to ask an EU Competent Authority (CA) to grant permission for legacy devices to continue being sold in the EU member state where the CA is located. These devices won’t receive final CE certification to the MDR before their Medical Devices Directive (MDD) or Active Implantable Medical Devices Directive (AIMDD) certificates expire. It should be noted that Article 79(1) MDR differs from Article 59 MDR, which only permits exemption of a legacy device for particular patients, institutions, or healthcare professionals.
EU MDCG 2022-18 aims to addresses the bottlenecks of notified body which led to delays in issuance of CE mark certificate resulting in non-compliant devices. This position paper outlines the documentation that a manufacturer or authorized representative must submit to their competent Authority in order to eligible for article 97 MDR provision. As CE mark certificate consultant, we create a technical file of necessary documents that can be submitted to the respective NB for the issuance of the certificate. To discuss your requirements and the changes related to this update, speak with our experts today.
The new extensions of MDR transition period to implement the regulations to replace medical device directives (MDD) by medical device regulations(MDR) is also proposed by the European Union (EU)
The key points to remember with EU MDCG 2022-18 update are
- EU MDCG 2022-18 only applies to legacy devices that fall under the scope of Article 120(3) MDR and for which MDD or AIMDD certificates have expired or will expires before the issuance of required MDR certificate(s).
- Regardless of how a leading CA rules on an article 97 MDR request, other CAs may decide differently on whether a certain legacy device is allowed to stay on the market in their region.
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