The European Commission have launched a public consultation on their proposal for a Directive on common rules promoting the repair of goods. This consultation is open until 22 May. This initiative promotes a more sustainable use of goods throughout their useful life. It will encourage consumers to make more sustainable choices by providing incentives and tools to use goods for…
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MHRA have confirmed that the timeline extensions for the EU MDR will apply in Northern Ireland, and certificates that have been extended will be recognised as valid for placing CE marked devices on the Great Britain market. This comes after the EU passed an amendment to the EU MDR and EU IVDR to amend the transition timelines for medical devices,…
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The amendment to the EU IVDR has been published in the Official Journal of the European Union. This removes the sell-off provision for IVD products, meaning that IVDs legally placed on the market under their IVDD certification can continue to be supplied to users indefinitely. This does not mean that new product can be placed on the market after expiry…
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There is an ongoing public consultation on priorities under the Ecodesign for Sustainable Products Regulations (ESPR). This consultation is open until 12 May. It is possible that this could affect certain medical devices such as adult incontinence products or substances used in production of medical devices and IVDs. Members are encouraged to review this consultation and provide feedback directly by…
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The MDCG have published their latest ongoing guidance update. The following IVDR-related documents are included in this list: Notified bodies Q&A on requirements notified bodies – update of MDCG 2019-6 (Permanent work item, no estimated date) Standards Updates of guidance document MDCG 2021-5 on standardisation for medical devices (Estimated Q2 2023) Post-market surveillance and vigilance Guidance on Post-Market Surveillance requirements (Estimated Q2…
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