The European Association of Medical Devices Notified Bodies (Team-NB) and The Association of British HealthTech Industries (ABHI) has submitted its response to the European Commission’s call for evidence on the targeted revision of Regulation(EU) 2017/745 Medical Regulation (MDR) and Regulation (EU) 2017/746) In Vitro Diagnostic Medical Regulation (IVDR).

The European Association of Medical devices Notified Bodies (Team-NB) has announced on 4 April 2025 that COVID-19 tests will be reclassified from Class D to Class B or C under updated Medical Device Coordination Group (MDCG) guidance 2020-16 Rev.04. The change follows expert panel advice that SARS-CoV-2 no longer poses a life-threatening risk to the European population. The reclassification removes requirements for batch verification, EU Reference Laboratory testing, and mandatory Common Specifications compliance. Team-NB advises affected manufacturers to contact their notified bodies regarding certification implications.

Team-NB has published a position paper on the European Commission’s draft implementing regulation on Annex VII, welcoming efforts to improve the regulatory framework but warning that proposed timelines are too short and risk feasibility, resource capacity and operational flexibility. The notified bodies’ association said on 22 December 2025 that the complexity of the proposal and constrained transition periods could undermine patient safety and timely access to innovative medical devices across the EU, and has therefore proposed more realistic timelines and additional changes for the Commission to consider.

The European Association for Medical Devices of Notified Bodies (Team-NB ) issued a press release to encourage its members to continually consider the possibility of issuing certificates with specific conditions, provisions, or limitations under Annex VII section 4.8 of both Regulation (EU) 2017/745 (the Medical Devices Regulation (MDR)) and Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation (IVDR)) (together the MD Regulations). Team-NB states that applying specific conditions, provisions or limitations to certificates can ensure that innovative, novel and orphan medical devices continue to be accessible to healthcare professionals and patients in the EU with appropriate surveillance safeguards in place. This is in line with the recent publication from the Co-ordinating Research and Evidence for Medical Devices (CORE-MD), which has highlighted the low volume use of certificates with conditions by notified bodies under the MD Regulations, but also highlighted the value of this mechanism to support innovation and encouraging increased use of such conditions under the MD Regulations.

The European Association of Medical Devices Notified Bodies (Team-NB) has published a legal expert opinion concluding that proposed Article 50 of the revision to the Regulation (EU) 2017/745 (Medical Device Regulation (MDR)) would unlawfully interfere with the freedom to conduct a business under Article 16 of the Charter of Fundamental Rights of the European Union (CFREU). The opinion states that the proposed measures, including mandatory fee reductions, deferred payments and the possible obligation for notified bodies to accept conformity-assessment requests, are disproportionate and exceed what is permitted under the Charter, despite pursuing legitimate objectives such as supporting small and medium-sized enterprises, promoting innovation, ensuring device availability and protecting public health. The analysis further argues that the proposal shifts the financial burden of these public-policy objectives onto private notified bodies without compensation or adequate cost safeguards. On this basis, the opinion concludes that Article 50 of the MDR would breach Article 16 of the CFREU and, if adopted in its current form, would be invalid and unenforceable.

Team-NB has published a position paper detailing how IVD Notified Bodies will manage the down-classification of SARS-CoV-2 tests following the MDCG 2020-16 rev.4 update, which reclassifies SARS-CoV-2 tests. Professional-use tests will move from Class D to Class B, self-testing devices to Class C, and multiplex devices will be assessed case by case. Manufacturers must submit a change notification with updated technical documentation, risk management files, and classification justification. Notified Bodies will review these changes and adjust certification processes accordingly.

The European Association of Medical devices Notified Bodies (Team-NB) has released a position paper proposing  the reclassification SARS-CoV-2 diagnostic tests from Class D to a lower-risk medical device class post-pandemic. Currently, coronavirus (COVID-19) tests are classified and regulated in the EEA as Class D in vitro diagnostic (IVD) devices according to Medical Device Coordination Group (MDCG) Classification guidance 2020-16 Rev. 2 further to Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation (IVDR)), Annex VIII Rule 1, 2nd indent.  In the paper, it considers the impact of reclassifying these tests as Class B according to IVDR Annex VIII rule 6 or Class C device according to Annex VIII Rule 3c, concluding that a reclassification to Class C would be recommended at this time given the limited availability of post-pandemic data. This would protect patient safety as stricter post-market surveillance (PMS) and performance evaluation/clinical evidence for these IVDs are applied. It further suggested that later reclassification to Class B could be considered once more data on the post-pandemic phase, especially regarding the long Covid syndrome, are gathered.

The European Association of Medical Devices Notified Bodies (Team-NB) has published  a letter on setting out its position on strengthening cybersecurity for medical devices in Europe and responding to proposed amendments to the Medical Devices Regulation and In Vitro Diagnostic Regulation. Team-NB welcomed efforts to improve cybersecurity for the benefit of patients and expressed support for proposals that clarify general safety and performance requirements and involve the EU Agency for Cybersecurity, while stressing that decisions on device availability and patient safety should remain within the existing MDR and Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation (IVDR)) governance structures. It also supported updating regulatory guidance and developing harmonised standards, noting that this would facilitate compliance, enable presumption of conformity, and reduce burdens, particularly for small and medium-sized enterprises.

The European Association of Medical Devices Notified Bodies (Team-NB) has published a position paper on the Medical Device Regulation (MDR) certification process under Regulation (EU) 2017/745 (MDR), outlining the steps that manufacturers and notified bodies should follow during the pre-application, application and post-application phases. The paper aims to promote greater consistency in certification activities across notified bodies, reduce incomplete submissions and improve the efficiency of application reviews. It details the information and documentation manufacturers are expected to provide and explains how notified bodies review applications, carry out conformity assessments and reach certification decisions. The paper also sets out post-certification surveillance requirements, including audits, technical documentation reviews, vigilance assessments and the evaluation of significant changes to devices or quality management systems.

The European Association for Medical devices of Notified Bodies (Team-NB) has issued a position paper that provides an agreement for the transfer of surveillance activities of legacy devices already placed on the market and certified under Directive 98/79/EC to be conducted in accordance with Article 110(3) of Regulation (EU) 2017/745 (the Medical Devices Regulation (MDR)). The MDR considerably increases manufacturers' obligations for surveillance of devices after they have been placed on the market, and the transition for legacy devices to comply with these increased surveillance activities is required under the MDR.

The European Association of Medical Devices Notified Bodies (Team-NB) has published a position paper on the European Commission’s proposed targeted revisions to Regulation (EU) 2017/745 (Medical Device Regulation (MDR)) and Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation (IVDR)). Team-NB supports measures aimed at improving predictability, transparency and efficiency in conformity assessment, and acknowledges that the MDR and IVDR have strengthened quality, clinical evidence and regulatory compliance across the sector. However, it notes that key initiatives, including the European Database on Medical Devices (EUDAMED) and the development of Common Specifications, remain incomplete and states that any further reforms should be evidence-based, realistic and implemented in a way that supports rather than disrupts the existing system. It also questions the Commission’s estimate of €2.1bn in conformity assessment savings, arguing that total notified body revenue in 2024 amounted to €475m, representing only a small proportion of the €170bn EU MedTech market. The paper further identifies positive elements in the proposal, such as increased digitalisation, strengthened regulatory dialogue and measures designed to facilitate innovation. It also addresses the proposed mandatory fee discounts for micro and small manufacturers, citing survey data indicating that 54% of such manufacturers placing devices on the EU market are based outside the EU, and outlining the potential implications for notified body revenues and broader market dynamics.

The three position papers released by Team-NB provide detailed guidance for manufacturers navigating complex EU medical device regulations. The documents were developed through extensive collaboration between Team-NB members to establish unified approaches across notified bodies.