Published in December last year, MDCG 2023-7 clarifies when clinical investigations are not mandatory for Class III and implantable devices. MDCG 2023-7 also shares updated guidelines for when data from equivalent devices may be used in a clinical evaluation under the EU Medical Device Regulation (MDR).
A key takeaway is the requirement for a contract with the manufacturer of the equivalent device is not necessarily required in all circumstances. Understanding this guidance is pivotal for companies looking to determine the best regulatory pathway as they innovate and attempt to maintain their products in the EU market.
To explore these changes and their implications further, we invite you to watch our live show. In it, regulatory and clinical experts unpack what the guidance means for MedTech companies. Chaired by a task force member behind MDCG 2023-7, the session covers everything from detailed interpretations of the EU MDR text to practical applications for products transitioning under MDR.
What You Need to Know
To prepare for the show, here are some key highlights of MDCG 2023-7:
- When Devices Are Exempt from Clinical Investigations — MDCG 2023-7 outlines the specific cases where Class III and implantable devices can be exempt from clinical investigations. Such exemptions are detailed under four distinct cases — in all cases, sufficient clinical evidence or data is needed:
- Devices designed by modifications to existing devices already marketed by the same manufacturer;
- Devices previously placed on the market or put into service under the medical device directives;
- Devices for which the manufacturer has a contract with another manufacturer they are claiming equivalence; and
- WET devices listed in Article 61(6)(b).
- Hierarchy Levels for Access to Equivalence Data — The guidance emphasizes the need for sufficient access to data to justify claims of equivalence between the device under evaluation and an equivalent device. The guidance outlines different access levels to clinical, technical, and biological data needed to show one device is equivalent to another. These range from having a contract in place or full access to the data to relying solely on publicly available information. Importantly, MDCG 2023-7 specifies that having a contract allowing full access to the technical documentation of the equivalent device is not required in all circumstances.
- How Documentation and Notified Bodies Factor In — Manufacturers must document their justification for claiming equivalence and exemptions in their Clinical Evaluation Report (CER), which must be accepted by the notified body. This includes detailing the level of access to the equivalent device's technical documentation and how it supports the claims of equivalence or exemption.
How MDCG 2023-7 Can Help You Drive Innovation
Embracing and understanding MDCG 2023-7 presents a strategic advantage for companies looking to innovate new and existing products — especially manufacturers offocused on Class III and implantable devices.
By clarifying exemptions for clinical investigations and understanding how to leverage data from equivalent devices, the guidance enables companies to more swiftly navigate the approval process. This accelerates the time-to-market for some Class III and implantable devices, ensuring faster patient access to critical healthcare solutions.
MDCG 2023-7 also helps ensure that product safety and regulatory compliance are never compromised. By detailing documentation and notified body involvement for equivalence claims, the guidance underscores the commitment to maintaining high quality and safety standards.
Unlock the Benefits of MDCG 2023-7 — Reserve Your Spot Today
Sign up for our live show for more insights on unlocking the benefits of MDCG 2023-7. You’ll gain strategies to reinforce your clinical data packages and insights on establishing “sufficient access” for equivalence claims. This workshop will also provide tips to help your devices succeed in the EU market.
Don't miss this opportunity to stay ahead in the MedTech industry. Sign up for free access to exclusive and expert insights on MDCG 2023-7.
Live Show Panelists
- Amie Smirthwaite BEng, Ph.D., FRAPS, — Senior Vice President, Scientific Affairs
- Jaishankar (Jai) Kutty, Ph.D. — Vice President, Intelligence & Innovation
- Jon Gimbel, Ph.D. — Vice President, Technical Consulting Services
- Bethany Chung, Ph.D., RAC — Principal Regulatory Scientist