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European Commission’s Missed Deadlines And Contingency Planning: Welcome To 2020!
2020 is not getting off to a good start for manufacturers needing to comply with the EU’s new Medical Device Regulation on 26 May 2020. The European Commission’s latest document seems to confirm industry’s fears about the ability of the EU’s medtech system to be ready in time.
The European Commission published an updated version of its EU Medical Device Regulation (MDR) and IVD Regulation (IVDR) Implementation Rolling Plan on 20 December 2019, when many in Europe had already left their desks for their festive holidays.
It is not full of festive cheer, however, nor of positive news for the New Year 2020.
On the contrary, this “update” is arguably more about what is not going to happen on time than what is going to be achieved by 26 May 2020, when the MDR fully applies.
MDR Less Than Five Months Away
There are now less than five months to go until the full implementation of the EU’s Medical Device Regulation. While certain product groups will be able to benefit from an extension of this deadline of up to four years, many products will not be able to use this. For those for which the extension does not apply, time is running out and the panic about not being ready in time is made all the more acute because many documents and structures needed within the context of the MDR are still not ready.
As time ticks down, the commission seems to be introducing an increasing number of delays and making concessions that will prevent many manufacturers from complying on time with the new regulations. This raises the likelihood of many products being removed from the market.
And at what cost to every player in the sector?
The current situation begs the question of whether, come 26 May 2020, patients in the EU are actually going to have a safer journey through their health care, or be exposed to more risk than they would have been if the directives were still in place, but tightened up in key areas.
One of the aims was to have the Eudamed 3 medical device database ready on time, but that is not going to happen, compromising communication and meaning that one of the most critical goals of the European institutions in redrafting the EU’s medtech rules will not be met. Another aim was to ensure certain products used on or in the human body but without a medical purpose would be regulated for the first time in Europe, but the documents needed for this are not ready. These are just a couple of examples of where critical structures are not going to be ready in time.
Below is a summary of what is arguably a sorry state of affairs:
Reprocessing – Contingency Planning
When it comes to the reprocessing of single-use medical devices, for example, while the commission still intends that the common specifications (CS) laying down reprocessing requirements would be ready by Q1 2020, it has made contingency plans should this not happen.
An implementing act is undergoing formal adoption it says in its Rolling Plan, but if the CS are not adopted by 26 May 2020, reprocessing will have to be performed in accordance with any relevant harmonized standards and national provisions.
CS For Aesthetic Products – Too Late?
There has been a great deal of skepticism among those in industry over the likely readiness of CS for products without a medical purpose for companies to be compliant with the MDR deadline, and it seems that this is for good reason.
Given that many of these products cannot benefit from the grace period because they are being regulated under the MDR for the first time, they must be compliant by 26 May 2020 to remain on the market after that date.
While the implementing act on CS for Annex XVI products, focusing of application of risk management, and where necessary, clinical evaluation regarding safety, is undergoing formal adoption, the deadline is Q2 2020.
This is going to put manufacturers of many of these products in limbo. If the products are not already in compliance with the MDD – and most are not because they do not fall under its scope – then it looks as if they will need to be removed from the market on 26 May 2020. That is unless the commission makes some provision for this product group to remain on the EU market.
Notified Bodies – Goal Not Met
When it comes to the number of notified bodies, it is no secret that the commission failed to reach its goal of having 20 designated by the end of 2019. Instead, there were just 12 that had been designated – 9 under the MDR and 3 under the IVDR.
The rolling plan indicates that the commission now expects “about 20 designations” to be completed in the course of Q1 2020.
However, the commission contends that things are not as bad as they seem. It says that by the end of 2019, “about half of existing certificates are covered by the notified bodies that will have a valid MDR designation in Nando [the notified body database] by the end of the year”.
Eudamed – Delay Confirmed
It has already been well documented that version 3 of the Eudamed medical device database is going to be delayed. This is confirmed in the rolling plan where the commission says that the deployment of a fully-functional Eudamed is expected by mid-2022. The commission also says that it is currently working with member states to provide guidance related to how certain new MDR provisions will apply in the absence of Eudamed.
For industry, the sooner this guidance appears the better, as there is not long to go for those who need to comply by May.
The commission also says that to support harmonization during the interim period, it intends to deliver the actor registration module by May 2020 “on a voluntary basis.”
Standardization Mandate – Where Is It?
The standardization mandate, so urgently required, has been delayed through no fault of the European Commission, but rather through changes going on at the European standards organizations (ESOs), CEN and CENELEC. Since standards are a cornerstone of the medical device directives and future medical device regulations, the delay in the availability of those which can offer a presumption of conformity with the requirements of the new MDR is serious and frustrating for industry.
On the brighter side, the commission says in the Rolling Plan that the draft mandate is undergoing the adoption procedure and that a decision is expected by Q1 2020. (The European Commission makes a request to the ESOs for development of standards – not least so the existing standards harmonized under the directives can be aligned to the new framework.)
What We Can Expect In Q1 2020
Two documents are due to be ready this quarter, according to the Rolling Plan:
The implementing act on rules listing the tasks of European reference laboratories under the IVDR;
The implementing act of the definition of fees for the advice and testing activities performed by the European reference laboratories.