MDCG encourages hybrid audits, other actions to improve notified body capacity

The European Commission’s Medical Device Coordination Group (MDCG) has listed a slew of actions to help streamline the work of notified bodies (NB), including encouraging notified bodies to conduct hybrid audits when doing so would speed conformity assessments. Stakeholders are anxious about the dearth of notified body capacity, which they fear could hold back products from the market.

On 26 August, the MDCG published a position paper after feedback from various stakeholders about their concerns with the lack of notified body capacity. The group published a 19-point position paper that it hopes will ease the situation.

“The MDCG recognizes that significant and urgent challenges remain in ensuring sufficient capacity of notified bodies and readiness of manufacturers in order to allow medical devices and in vitro diagnostic medical devices to be certified in accordance with the MDR and the IVDR within the transition periods provided for in the regulations,” said the group. “The data gathered to date indicate that there are multiple causes which require a mix of solutions.”

European Union health ministers raised the issue about the lack of NBs at the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council meeting on 14 June 2022. They expressed concern that the lack of capacity could lead to disruptions in the medical device supply chain and jeopardize market access to innovative new treatments and diagnostics in the region. The ministers asked MDCG to propose ideas on how to address the challenges.

The MDCG’s position paper is divided into three categories including what steps can be taken to increase the capacity of NBs, increase access to NBs and other steps that can be taken to transition to the EU’s Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR).

To increase the capacity, the MDCG said NBs should make use of hybrid audits when conducting conformity assessments of sponsor products. The group said this should help streamline reviews but stay within regulations.

The MDCG also advised NBs to use past experiences from auditing products to avoid redoing much of the work.

“In order to avoid unnecessary duplication of work, the MDCG encourages notified bodies to develop a framework for leveraging evidence, or components thereof, from previous assessments conducted with regard to requirements under the directives for the purpose of conformity assessment procedures under the regulations, provided that duly qualified notified body personnel deem the previous assessments by the same or another notified body valid and properly substantiated also with regard to the MDR/IVDR requirements and the device under assessment,” the group wrote.

One of the biggest issues is how to ensure legacy devices can stay on the market once the regulations go into full effect.

The MDCG said there should be flexibility given to the review of legacy products as long as they are deemed relatively safe and effective. The group recommended stakeholders, including legacy device makers, follow the flexibility proposed in its previous guidance MDCG 2022-4 which includes combining audits under the directives and the regulations for ‘legacy devices’ whose application for MDR/IVDR certification is being reviewed by the notified body, focusing on assessment of compliance with MDR/IVDR requirements instead of surveillance of compliance with directives’ requirements, and abandoning sampling plans for technical documentation assessments under directives.

“The MDCG considers that, in particular for safe and effective legacy devices, including orphan devices, the complexity of conformity assessments should be reduced and more pragmatism ensured with regard to the demonstration of compliance with the applicable requirements,” the group added.

With that in mind, the MDCG said it will work to produce more guidances on legacy and orphan devices that will help reduce regulatory ambiguity and give device-makers more flexibility. While it plans to develop a better guidance defining orphan devices and helping them meet their legal requirements, the group also asked EU regulators to accept and efficiently process consultations by notified bodies.

Another key area of concern for stakeholders is how to help small and medium-sized enterprises (SME) that have less regulatory experience and higher administrative burdens when trying to get products to market.

The MDCG reminded NBs that they are required to make their standard fees public, especially with SMEs in mind, and encouraged them to format the fees in a way that makes them easy to compare.

“Moreover, the MDCG calls on notified bodies to develop schemes in order to allocate capacity for SME manufacturers and first-time applicants and ensure access of SMEs and first-time applicants to notified bodies for conformity assessment,” the group said. “In order to increase preparedness of manufacturers, especially SMEs and first-time applicants, to adapt to the high-level standards set up by the regulations, the MDCG calls on all parties involved to continue and, where possible, to step up communication with manufacturers by means of webinars, workshops, targeted feedback and informative sessions.”

MDCG encourages hybrid audits, other actions to improve notified body capacity

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