A New Reality: EMA Published First Guidance on New MDR/IVDR Rules for Certain Devices

The increasing pace of innovation and blurring boundaries between pharma and device products have led to new drug-device combination products and the need for updated regulatory guidances.

As a result, the European Medicines Agency’s (EMA’s) Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) and the European Commission published a Q&A document detailing information for products that need both the drug and the device components to function. This document is the first in a series of guidances to help manufacturers prepare for compliance under the new EU MDR and IVDR rules.

This initial document focuses on the implementation of Article 117, which introduced a new requirement for notified body (NB) involvement in the development of a medicine with an integral medical device. Examples of these products include pre-filled syringes and pens, patches for transdermal drug delivery and pre-filled inhalers. In addition to outlining definitions, the Q&A document summarises changes for marketing authorisation applications for these products, including the need to have the results of conformity assessments by NBs in the submission.

As the EMA and EU regulatory network work with stakeholders from the pharmaceutical and medical device industries, including NBs, to ensure a smooth transition to the new regulatory framework by May 2020 for medical devices and May 2022 for in vitro diagnostic medical devices, they plan to publish future updates to the Q&A document. During this transition period, manufacturers, NBs and authorities will need to comply with the changes.

Next year, when the regulations are in force, applications covering devices that already have a CE mark must include a declaration of conformity and an EU NB certificate, while devices without a CE mark will have to include a NB opinion statement.

Future additions to the Q&A document may include topics such as devices made of substances that are systemically absorbed, borderline products, and in vitro diagnostic tests used to determine patients’ eligibility for specific medical treatments.

Shaping a New Reality for Manufacturers

Given the short timelines and tightening resources, manufacturers should submit the documentation to support declaration of conformity or NB opinion at the time of submission to avoid any delays. Keep in mind, approximately one in four centrally authorised medicines have a medical device component and most of these incorporate an integral device, which will further add to the already long queue of products needed to be reviewed by NBs. Manufacturers will need to integrate regulatory and financial teams to develop new business strategies to ensure market share for products.

Adopting a strategic partner with regulatory expertise can help companies with the strategic planning needed for ensuring necessary documentation and clinical evidence for compliance under the new MDR and IVDR regulations.

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