As you will be aware from previous blog posts, the new EU Medical Devices Regulations (the MDR and IVDR) will be applicable in May 2020 (for medical devices) and May 2022 (for in vitro diagnostic medical devices). The European Commission and medical device coordination group (MDCG) are busy preparing the guidance documents and implementing legislation to ensure the Regulations can function. Notified bodies are also going through the designation procedure to ensure they can accept applications under the MDR and that products can be placed on the market under the new Regulations. However, there is still much to do, and progress has been slow. We set out below an update on the current state of play.
As we approach one year to go before the application of Regulations (EU) 745/2017 (Medical Devices) and 746/2017 (In Vitro Diagnostic Medical Devices) (applicable in May 2020 and May 2022, respectively), the European Commission has updated its website to collate all of its guidance on the legislation. This includes a recently published series of nine non-binding practical reference guides, which is now available in a new section of the website entitled “Spread the word” – part of the Commission’s campaign to “inform as many stakeholders as possible about their roles and responsibilities under the new Regulations“. In particular, they consist of:
Data-driven technologies, particularly artificial intelligence and other complex algorithms, have the potential to enhance patient care and catalyse medical breakthroughs. However, these technologies are heavily reliant on data, which poses challenges in ensuring that patient information is handled in a safe, secure and legally compliant way.
In response to early issues with the deployment of artificial intelligence and other algorithmic tools in healthcare, on 5 September 2018 the UK Department of Health & Social Care (DH) published an Initial Code of Conduct for Developers and Suppliers of Data-driven Health and Care Technology (the Code). The Code is not legally binding but aims to raise standards by establishing best practices.
Last week, MedTech Europe, the European trade association representing the medical technology industries, published a position paper calling on the European Commission, Parliament and EU Member States to extend the transition period under the Medical Devices Regulations (the MDR and the IVDR). As mentioned in one of our earlier blogs, the MDR and IVDR are due to take effect on 26 May 2020 and 26 May 2022 respectively. The position paper explains that the medical technology industry has “significant concerns” about the state of implementation of the Regulations, and the fact that if products are not re-certified before the date of application of the Regulations, they will not be able to be placed on the market, and the industry will be unable to provide life-saving and life-transforming products to patients.…
The META Tool is an online service that provides developers of medical devices, diagnostics, digital health interventions, and medical apps with a framework to help them identify potential gaps in the available evidence, and prepare for discussions with investors, health technology assessment organisations (including NICE itself), and payers.