Navigate the complexity of EU medical device regulations with confidence by understanding how technical standards support compliance, safety and market access.
Medical devices are among the most highly regulated products in the world. Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), manufacturers must demonstrate compliance with detailed legal and technical requirements, while keeping pace with evolving standards and interpretations. This technical report explains the critical role standards play in achieving regulatory compliance, standardization and harmonization across the EU market.
Drawing on practical regulatory experience, the report explores how harmonized, international and national standards are used to support conformity with MDR and IVDR requirements. It also addresses common challenges, such as managing multiple versions of standards, dealing with gaps where harmonized standards are unavailable and demonstrating compliance when transitioning from MDD to MDR.
What you’ll find in our white paper
- The role of technical standards under MDR and IVDRLearn how technical standards support conformity with General Safety and Performance Requirements (GSPRs) and how harmonized standards create a presumption of conformity when cited in the EU Official Journal.
- Standardization and harmonization explainedUnderstand how international standards are developed, adopted as European standards and harmonized under EU regulations, including the role of ISO, IEC, CEN and CENELEC in the process.
- Managing versions, amendments and transitionsExplore the practical differences between editions, amendments and corrigenda, and how manufacturers can manage updates, withdrawals and transition periods without disrupting compliance.
- Prioritizing standards when harmonized options are limitedGain clarity on how to justify the use of international, national or in-house standards when harmonized standards are unavailable, including a clear hierarchy for selecting alternative sources.