In December 2019, the EU Commission released the 2nd corrigendum which effectively amended the existing EU Medical Device Regulation 2017/745 (MDR) and introduced new transitional provisions for self-certified devices under the previous Directive.
Class I medical devices under the EU Medical Device Directive 93/42/EEC (MDD) that have been “up-classified” under the new rules of the EU MDR, and thus now require Notified Body intervention, have been provided additional grace allowing them to continue being placed on the EU market until 26 May 2024 in compliance with the Directive. These are called “legacy products” and include:
- Reusable surgical instruments.
- Certain types of software up-classified under the new Rule 11.
Although these devices may continue to comply with the MDD requirements, Article 120 does have some T&Cs to take into account, including the application of the following MDR requirements:
- Post-Market Surveillance.
- Market Surveillance.
- Registration of Manufacturers and Medical Devices.
To clarify, Class I devices under the MDD which remain Class I under the MDR and which do not require the intervention of a Notified Body will need to comply with all the requirements of the MDR by 26 May 2021 to continue being placed on the market.
How We Can Help #
The eligibility of Article 120 for your product hinges on its classification rationale under both the EU MDD and MDR, as well as the product’s intended purpose. We have many years of experience putting such documents together. Take a look at our services on our Regulatory Consulting page for more information, or get in touch with us today to learn more.