The European Commission’s Medical Device Coordination Group (MDCG) is alerting that medtech manufacturers get certified under the new device and diagnostics regulations as soon as possible, possibly being the strongest warning to the industry yet. It is also calling on notified bodies to provide more clarity and certainty.
While there are more than 24,000 medical devices under the Medical Device Directive (MDD) that need to be transitioned to MDR, manufacturers have only submitted 13,000 devices for certification to MDR, and just 3,900 certificates have been handed out through June 2023, according to MDCG.
On 29 November, MDCG published a position paper stating that while significantly more manufacturers have applied to have their products certified under the new European Union (EU) Medical Device Regulation (MDR) or In Vitro Diagnostics Regulation (IVDR), several deadlines were extended, and not enough are taking advantage of the new timelines. Manufacturers risk having their products dropped from the market if they do not apply promptly.
Manufacturers have only submitted 13,000 devices for certification to MDR. Only 3,900 certificates have been handed out through June 2023, according to MDCG, while there are more than 24,000 medical devices under the Medical Device Directive (MDD) that need to be transitioned to MDR. Additionally, about 1,000 of the certificates that have been handed out for devices are related to updates, according to MDCG. The tendency to transfer devices that are included in the same certificate could hamper the ability of NBs to plan and handle capacity. “The situation is even more worrisome for IVDs,” MDCG wrote. “While only around 8% of IVDs required notified body involvement for conformity assessment under Directive 98/79/EC on in vitro diagnostic medical devices (IVDD), this proportion is around 80% under the IVDR.”
“Nonetheless, compared to around 1,500 certificates issued under the IVDD (representing a small fraction of the number of certificates expected under the IVDR), by June 2023, only 1,150 applications have been lodged under the IVDR and around 500 certificates have been issued,” the group added. MDCG asks manufacturers to keep in mind that the conformity assessment process currently takes longer under the new regulations, compared with the previous directives.
An important factor in the longer term is that the majority of applications submitted are incomplete, according to data from notified bodies. They have been urging manufacturers to apply for certification before the end of the year and to ensure the applications are complete and of high quality. “Considering the deadlines established by the Regulations, manufacturers are thus urged to strengthen their efforts to transition as soon as possible and not to delay submissions further, as this could lead to bottlenecks in the work of notified bodies and possible shortages of products in the market,” MDCG wrote. “This is particularly true for manufacturers of class D IVD devices, which must transition to IVDR by May 2025.”
MDCG Predictability is Paramount
MDCG also urged notified bodies to do their part in making the transition more efficient, transparent, and predictable, especially for small and medium-sized enterprises (SMEs), and said that the lack of regulatory guidance and technical information on how to apply for conformity assessment has been a major problem for manufacturers, leading to incomplete applications that need to be addressed by notified bodies.
“It is essential that notified bodies streamline their procedures and make all needed efforts to improve their conformity assessment activities in terms of transparency, timelines, predictability and consistency,” MDCG wrote. “Notified bodies are reminded to operate in accordance with consistent, fair, and reasonable terms and conditions, taking into account in particular the interests of SMEs in relation to fees.”
“The MDCG reminds notified bodies to organize structured dialogues with manufacturers, which is expected to be part of the normal pre-application and conformity assessment activities and therefore not to be a separated service to be charged for,” the group wrote. “The MDCG calls on notified bodies to increase transparency around their capacity and timelines for conformity assessment and specifically to make publicly available, ideally on a common website, specific information on capacity available at each notified body across the EU for both MDR and IVDR.”
The Role of Eclevar in Facilitates the Regulatory Adherence
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