Major Concerns Remain With MDR, Industry Group and Expert Warn

Regulatory NewsRegulatory News | 10 January 2020 |  By 

As the 26 May date of application for the Medical Devices Regulation (MDR) approaches, lingering concerns about notified body (NB) capacity, a lack of guidance and the two-year Eudamed delay are beginning to get more serious.
Earlier this week, industry group MedTech Europe outlined some of the challenges in a “call to action,” while also explaining the risk of device shortages. Currently, 55 NBs are legally allowed, until 26 May, to renew or extend the validity of device certificates issued under the former device directives, but their capacity to do so “is extremely limited, putting at risk the continued availability of existing devices.”
And with only nine NBs designated under MDR, future challenges await.
Maurits Lugard, a Brussels-based partner in Sidley Austin’s global life sciences practice, told Focus via email: “Even with experience gained from the MDR joint assessments and the anticipation that future assessments and accreditations will go faster, it will still be very difficult to ensure that enough Notified Bodies are designated by 26 May. Also, even if we did have a large number of Notified Bodies available, the fact that the MDR introduces stricter requirements means that the certification process itself may take more time than in the past.  Lastly, we are still waiting for a large volume of guidance documents.”
Indeed, MedTech Europe noted that one of the key guidance documents is necessary for device certificates renewed under the current directives that may only remain valid if the devices see no significant changes to their design and intended purpose after 26 May. And yet, there is not any guidance on what a “significant change” will mean.
“Therefore, while many devices may be eligible for the MDR Grace Period in theory, the lack of needed guidance presents the risk that renewed certificates may quickly lose their validity after 26 May 2020, e.g., due to changes which are outside the manufacturers’ control,” the group explains.
MedTech Europe added that the device industry is seeing severe delays in NB assessments of files submitted and the rejection of files for devices that are eligible for the MDR grace period. “Furthermore, it is expected that there will be assessments still unfinished on 26 May 2020, and this means solutions need urgently to be found,” the group said.
Despite these concerns, European Commissioner for Health Stella Kyriakides said last month that the MDR deadline in May is not changing and that interim solutions for the two-year delay of Eudamed will be set up.
Sidley Austin’s Lugard added: “I expect that the application of the MDR will not be delayed. However, although the MDR addresses how certain of its requirements will be affected by the Eudamed delay, it still remains unclear how Member States intend to address the many requirements that are indirectly affected. Several options are currently on the table – voluntary, non-enforcement, etc. Hopefully, Member States and the Commission will soon decide so that industry can get ready.”

Eudamed Nomenclature
As the concerns continue, the European Commission on Friday released new documents on the Eudamed nomenclature’s basic principles and the structure of the Italian “Classificazione Nazionale Dispositivi medici” (CND), which was selected last March as the basis for the future European Medical Device Nomenclature.
The CND is currently used in Italy, Portugal and Greece and about 15,000 manufacturers from various countries have used it for the registration of devices and in vitro diagnostic devices in the Italian database.
The system works by classifying each medical device with an alphanumeric code consisting of a letter referring to the “Category,” such as dialysis devices or hematology and hemotransfusion devices, a couple of numbers referring to the device “Group” and a series of other numbers referring to the “Type” of device. More details on the CND structure are included in the guidance.
Meanwhile, the commission said it is also currently collaborating with the World Health Organization (WHO) on a future international medical device nomenclature. Last February, WHO discussed some of the progress on the international nomenclature.
The CND Nomenclature - background and general principles
The European Medical Device Nomenclature (EMDN) - the nomenclature of use in EUDAMED

Editor's note: This article was updated on 1/24/20 to note that device certificates renewed under the current directives may only remain valid if the devices see no significant changes to their design and intended purpose after 26 May. We'd had previously written "design or intended purpose." We regret the error.


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