The New Year has seen the official publication of a series of long-awaited new medtech standards, including some that are critical to large swathes of the medical device industry.
It’s official! The updated version of the EU quality system standard EN ISO 13485, which is relevant for the whole of the medtech industry, is now formally recognized as a “harmonized” standard in the context of the EU’s Medical Device Regulation.
The Council of the EU has followed the European Parliament in rubberstamping the European Commission’s proposal for selected IVDR transition deadline extensions, as expected. Industry has expressed relief, but points to other outstanding IVDR issues that also need urgent EU attention.
There is growing impetus at the highest EU levels towards ensuring the IVD Regulation is implemented as quickly and effectively as possible. Discussions at the Council of the EU have now been added to this drive.
European Commissioner for Health and Food Safety Stella Kyriakides is calling on EU member states to “equip your authorities with the resources they need” to deal with the 11 pending applications for notified body designation under the IVD Regulation.
So far, there are just six notified bodies designated under the IVDR.
The EU Medical Device Regulation applied in May, but the 200 or so associated standards that support it remain in the early stages of preparation. A few have been issued, and now industry can expect a small second wave later in 2021.
In a best-case scenario 61% of today’s IVDs will be certified by the 26 May 2022 IVD Regulation deadline, and in a So far, only five standards have been published in the Official Journal of the EU in the context of the EU’s Medical Device Regulation, and four in the context of the IVD Regulation.
But more standards are due to be officially published this year, including the European versions of the international quality system standard EN ISO 13485 and of the risk management standard EN IS0 14971, standards that are the very foundation of the implementation of the MDR and IVDR but which are now going to be officially available later than the originally anticipated October deadline.
With just six notified bodies designated under the IVD Regulation, and amidst repeated warnings of insufficient auditing capacity, the EU could lose between three-quarters and over a half of its IVDs, a recent survey warns.
In a best-case scenario 61% of today’s IVDs will be certified by the 26 May 2022 IVD Regulation deadline, and in a worst-case scenario only 24% will be, a survey recently conducted by EU medtech industry association MedTech Europe found.
The conditions for this crisis situation have mainly arisen because, while just 8% of IVDs need a notified body certificate under the currently applicable IVD Directive, 78% will need notified body involvement under the IVDR. That is according to the organization’s latest estimates.
The biggest loss, it predicts, is likely to come from SMEs who make niche products in smaller volumes and who may be less able to endure loss of business, MedTech Europe says.
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In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
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