The much-anticipated updating of both the Medical Device Directive (93/42/eec) and the In Vitro Medical Device Directive (98/79/ec) have finally been formally approved. The next step for the new MedDev and In Vitro MedDev Regulations is publication in the Official Journal. This is expected in early May. The official transition period should begin in June. The new Regulations should be fully in force in three years for Medical Devices, and in five years for In Vitro Medical Devices.
The new MedDev and In Vitro MedDev Regulations have been in process for the last 8 years. This is the first major revision of the Directives issued in the 1990’s.
Changes to the Medical Device Directive appear to be primarily a modernization of the original rules. You can expect to see best practices from existing Commission guidance to now be included. During your transition, plan to implement requirements that have been the subject of recent harmonization. This is particularly true in the areas of risk management and clinical evidence. Expect to tighten up your control over your supply chain as well.
In the In Vitro Medical Device arena, you have a longer timeline for compliance with the new rules. This implies that there are still areas needing clarification during the “secondary legislation” phase. That said, the Regulations are a major update for the rules for these devices. The use of 4 risk-based classes, with differing levels of requirements, will mean more extensive use of Notified Bodies during the certification process. Performance evaluations, distribution requirements and “responsible person” requirements will all impact your certifications.
Once the 2 new regulations are published in the Official Journal, the clock is ticking. The official text of the new regulations will be available at that time (likely early May). Please send us an email (email@example.com) if you need copies. Use “New MedDev Regs” as the subject and we’ll reply with your complimentary copies as soon as they are issued.
If you need assistance with the many standards on the Harmonized Lists for these two Regulations/Directives, please let us know. You can search for and order standards at our webstore, www.document-center.com. But many of our customers do have questions regarding which editions to choose, transition times, and so on. Don’t hesitate to reach out to us. We’re your Standards Experts!