It does not happen very often that Commission asks for such a delay but it's an »extraordinary measure for extraordinary times«. The Covid-19 pandemic increases demands for certain vital medical devices (masks, gloves, overalls, ventilators…). Manufacturers and other economic operators as well as health institutions are overloaded. Commission hopes »this postponement will take the pressure off national authorities, notified bodies, manufacturers, and other actors so they can focus fully on urgent priorities related to the coronavirus crisis«. It is a pragmatic approach where currently applicable rules will continue to guarantee the protection of public health.

In addition, the proposal also allows in this period individual Member States to authorize medical devices without a CE mark in their respective territories if there is a public health or patient safety or health interest and allows the Commission to extend the EU Member States’ decision to the entire EU market for a limited period of time.

The proposal does not change the implementation date for the new Regulation on In Vitro Medical Devices (IVDR - 2017/745/EC), but the similar approach may also be expected since IVD industry is facing problems due to increased demands and slow designation of notified bodies under the IVD Regulation.

From pharmaceutical regulatory point of view EU addressed the issue by introducing new legislation on Orphan medicines in 2000 aimed at increasing therapeutic choices for patients suffering from rare diseases. It established a centralised procedure for the designation of orphan medicinal products and put in place incentives for their research, development and marketing. Pharmaceutical companies can benefit from incentives such as fee waivers, scientific assistance for marketing authorisation and the possibility of an EU marketing authorisation with a 10-year market exclusivity period. But the extent of the use of the incentives and their effect to R&D stimulation was not as expected (evaluation in 2015). This is why the Orphan Regulation is now together with the Paediatric Regulation (showing the similar weaknesses) at the final stage of evaluation by Commission under the Commission's Better Regulation principles.

Why is the Commission evaluating the two Regulations together?

Both regulations have the similar objectives – to increase therapeutic choices for patients suffering from rare diseases and children. Both regulations introduced set of obligations, rewards and incentives, but the extent of their use and of their effect to R&D stimulation was not as effective as expected. Economic risk outweights benefits of the incentives. In addition, designations seem to overlap in some cases. Both regulations need revisiting the definitions (e.g. of a »benefit«,  »reward«, »incentive«, »designation«…), the concept of rarity (by incidence, prevalence or the nature of the disease…) the concept of the »unmet needs«.

Nevertheless, problems in practice will not be solved by any new/changed piece of legislation alone but must include additional national efforts and coordinated actions of EU Member States.

• Sustainable innovation (e.g. improving the regulatory environment for ATMPs, better regulation and common understanding on innovative “borderline” products, examination of the variations framework…)
• Access and affordability while addressing shortages, and unmet medical needs (e.g. Evaluation of the legislation on orphan and paediatric diseases, reinforcing obligation to supply and addressing shortages, measures on parallel trade, supporting not - profit organisations and academia in drug repurposing…)
• Security and oversight of the global manufacturing supply chain (e.g. Reducing dependency on API from third countries especially for “strategic” medicines and vaccines

Although the working priorities identified by the Pharmaceutical Committee cannot be considered as Commission priorities, the planned activities (particularly the ongoing ones) indicate the direction of the changing shape of EU pharmaceutical regulation.