EMA Announcements Regarding Nitrosamine and MDRs

The EMA published information on two topics this week that will be of interest to firms who distribute product in the EU. The information addresses changes in due dates and application dates for:

1. Completion of risk assessments regarding the potential for nitrosamine formation in chemically synthesized APIs
2. Implementation of the new Medical Device Regulation (MDR) requirements

EMA Actions for MAHs of human medicinal products containing chemically synthesized APIs

On September 19, 2019, the EMA identified actions for marketing authorization holders (MAHs) of human medicinal products containing chemically synthesized APIs. The firms are to identify potential risks for the formation of nitrosamines and make changes to the manufacturing process.

Step 1 of the activities required by firms is the completion of a risk assessment to identify products that may be at risk of nitrosamine contamination. Previously, the deadline for completion of the risk assessments was the end of March 2020. The EMA announced on March 27, 2020 that the completion date for the risk assessments is delayed until October 1, 2020, based on the challenges faced by companies in completing the risk assessments and the shift in priorities accompanying the COVID-19 pandemic. The EMA encourages manufacturers to submit the outcome of their risk assessments before October 2020 if they are completed or, more importantly, if they identify a risk to their products.

Firms should communicate with their national competent authority as soon as possible if testing confirms the presence of nitrosamines, even if the level is below the limits set by health authorities. Please note, the announcement includes a variety of templates for use in completing the exercise required by the authorities.

Deferred Application Date of the Medical Devices Regulation

The EC announced on March 25, 2020, that they are working on a proposal to defer the application date of the Medical Devices Regulation for one year. The current application date for this regulation is May 2020.

The intent is to submit the proposal for this delay by early April so that it can ideally be adopted by the Parliament and Council by the end of May 2020.

According to the EC, “This will take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis.“ The new regulations include significant improvements in the current system, including:

• Stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level.
• Reinforcement of the criteria for designation and processes for oversight of notified bodies.
• Inclusion of certain aesthetic devices that present the same characteristics and risk profile as analogous medical devices under the scope of the regulations.
• A new risk classification system for in vitro diagnostic medical devices in line with international guidance.
• Improved transparency through a comprehensive EU database on medical devices and a device traceability system based on unique device identification.
• Introduction of an ‘implant card’ for patients containing information about implanted medical devices.
• Reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorising multi-centre clinical investigations.
• Strengthening of post-market surveillance requirements for manufacturers.
• Improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance.