Advanced Medical Technology Assoc.
AdvaMed
AdvaMed's mission is to advance medical technology to improve patient lives and promote a healthy global economy by advocating for patient access to safe, effective, and innovative technologies, and promoting ethical standards and competitive policies.
ID: 822761899136-02
Lobbying Activity
Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics
4 Oct 2025
Overall: AdvaMed believes that the current issues in MDR/IVDR implementation are best addressed through application of both short-term measures, to be implemented as soon as possible, ideally this year, in combination with longer-term measures, as outlined in these two papers: medtech-europe_mdr_ivdr_leaflet_four-urgent-targeted-measures-1.pdf; joint-discussion-paper-on-future-governance-of-medical-technologies.pdf. Need to Reduce Administrative Burden and Improve Consistency and Transparency in Certification Processes. AdvaMed has observed that despite recent progress, manufacturers still face unpredictable timelines and costs in securing device certification in the EU. Different interpretations and implementation of regulations by different Notified Bodies have led to inconsistent outcomes for similar products. A lack of publicly available performance data from Notified Bodies, as well as clear timelines and costs, clouds accountability and makes it difficult for companies to make informed decisions. We support the following: Enforceable timelines for conformity assessments Annual performance disclosures from Notified Bodies Harmonized documentation requirements for notified bodies. Utilization of a structured dialogue process between manufacturers and Notified Bodies. Making requirements for clinical investigations and performance studies more efficient and risk-proportionate. Elimination of duplication in post-market surveillance reporting Reporting requirements overall should be made more risk-proportionate. There should be a clear, precise definition of substantial change to encompass any modification that could adversely impact 1) the safety or performance of a medical device; 2) the devices intended purpose or its prescribed conditions for use; 3) the manufacturers QMS compliance with the legislative requirements. Need to better align the EU with Global regulatory standards. Regulatory fragmentation in the European Union discourages investment to the expenses of new product launches and innovation in the EU. Utilization of IMDRF as a guide to harmonize key concepts, and recognition of MDSAP audits for EU market access, will increase efficiency and incentivize innovation to the EU by allowing manufacturers to meet multiple regulatory requirements through a single audit. Tailored Documentation for Different Study Types The IVDR currently applies identical documentation rules to both analytical and clinical studies, despite their distinct goals and methodologies. This creates unnecessary complexity and delays without improving safety or data quality. Policy Recommendation: Update Annex XIII to establish differentiated documentation requirements that reflect the specific nature and risk profile of analytical versus clinical performance studies. AdvaMed believes the MDR/IVDR implementation is in need of both short-term measures to be implemented this year, and longer-term measures, as outlined in these two papers: //www.medtecheurope.org/wp-content/uploads/2025/05/medtech-europe_mdr_ivdr_leaflet_four-urgent-targeted-measures-1.pdf; https://www.medtecheurope.org/wp-content/uploads/2025/03/joint-discussion-paper-on-future-governance-of-medical-technologies.pdf AdvaMed believes that Despite recent progress, manufacturers still face unpredictable timelines and costs in securing device certification, complicating market planning. Different implementation of regulations by Notified Bodies results in inconsistent outcomes for similar products. The lack of publicly available performance data from Notified Bodies, clear timelines and costs, makes it difficult for companies to make informed decisions. Recommendation: Implement enforceable timelines for conformity assessments, require annual performance disclosures from Notified Bodies, and ensure harmonized documentation requirements. Regulatory fragmentation in the European Union discourages investment to th
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