The European Medicines Agency has published guidance for developers of drugs that feature an integral medical device component, such as pre-filled syringes and pens.
The question and answer document is the first in a series of guidelines EMA plans to release to help companies adapt to its incoming medical device regulations.
The regulations will place new responsibilities on developers of drug-device combinations, prompting EMA to prioritize the creation of guidance on the topic.
The medical device regulations due to come into force in the European Union in May 2020 feature a section on medicinal products with integral medical devices, such as pre-filled inhalers and patches for transdermal drug delivery. These products, which account around 25% of centrally-authorized medicines in the European Union, need the both drug and device component to function.
In light of the importance of the device component to these products, the EU is set to make marketing authorization applicants include the results of conformity assessments by a notified body in their submissions. The guidance deals with the implications of this requirement.
Once the regulations come into force next year, applications covering most devices that already have a CE mark must include a declaration of conformity and an EU notified body certificate. If the device lacks a CE mark, the applicant must include an opinion from a notified body.
The rules for medicinal products incorporating Class I devices that are non-sterile, non-measuring or non-reusable surgical instruments are slightly less onerous. For these low-risk devices, EMA wants applicants that have a CE mark to include a declaration of conformity. If the device lacks a CE mark, the applicant does not need to include an opinion from a notified body.
EMA will only apply the rules to filings it receives after the regulations come into force, so products that are awaiting regulatory review or on the market at that time will be exempt. However, EMA will enforce the rules if a company makes a substantial change to the design or intended purpose of the device component of an approved combination product.
The guidance is the first in a series of planned publications on categories of devices affected by the regulations, including in vitro diagnostics used to determine eligibility for a treatment and products made from substances that are absorbed systemically. EMA will discuss these topics in new sections it plans to add to the document that already features the drug-device combination product guidance.