the medicinal product is already authorised through the centralised procedure, or.

the medicinal product falls exclusively within the scope of the centralised procedure for the authorisation of medicines, or.

Role of EMAīefore it can issue a CE certificate, the notified body must seek a scientific opinion from EMA on the suitability of the companion diagnostic to the medicinal product concerned if: The Regulation applies from, following a five-year transition period. The In Vitro Diagnostic Devices Regulation ( Regulation (EU) 2017/746) introduces a new classification system for companion diagnostics and the obligation to undergo a conformity assessment by a notified body.

Ancillary medicinal substances in medical devicesĪ companion diagnostic is an in vitro diagnostic test that supports the safe and effective use of a specific medicinal product, by identifying patients that are suitable or unsuitable for treatment.

in cases where EMA has already evaluated a medicine containing the same medicinal substance.ĮMA publishes consultation procedure public assessment reports (CPAR) on its scientific opinions.įor information on the consultation procedure to seek an EMA scientific opinion, see:

catheters coated with heparin or an antibiotic agent īefore it can issue a CE certificate, the notified body must seek a scientific opinion from EMA on the quality and safety of the ancillary substance if it is derived from human blood or human plasma, or if it is within the scope of the centralised procedure for the authorisation of medicines.įor other substances, the notified body can seek the opinion from a national competent authority or from EMA e.g.

This clarifies expectations laid down in Directive 2001/83/EC and addresses obligations in the Medical Devices Regulation, in particular under Article 117.ĮMA recommends reading the guideline in conjunction with the Q&A on the implementation of the Medical Device Regulation and In Vitro Diagnostic Devices Regulation.Ī medical device may contain an ancillary medicinal substance to support the proper functioning of the device. These products fall under the medical devices legislation and must be CE marked.Įxamples of medical devices with an ancillary medicinal substance include:

The medical device may be co-packaged with, obtained separately from or integral to the medicinal product.ĮMA issued a final guideline on quality documentation for medicinal products that include a medical device in July 2021. Must be CE marked in accordance with EU medical devices legislationĮMA is responsible for evaluating the quality, safety and efficacy of marketing authorisation applications assessed through the centralised procedure, including the safety and performance of a medical device in relation to its use with a medicinal product.tablet delivery system with controller for pain management.Medicinal product and device are separate items contained in same pack or obtained separately.

Requirement does not apply to Class I devices (non-sterile, non-measuring).Requirement applies since under article 117 of Medical Devices Regulation.Marketing authorisation application should include a CE certificate for the device or, if not CE marked but would need to be certified if marketed separately, applicant must include an opinion from a notified body on conformity of device.Medicinal product and device form a single integrated product.Notified body must seek scientific opinion of a competent authority - EMA provides scientific opinion on compliance of substance with requirements in Annex I of Directive 2001/83/ECĮMA supports medical device expert panels that provide opinions and views to notified bodies on scientific assessment of certain high-risk medical devices and in vitro diagnostics Medical devices made of substances that are systemically absorbed Notified body must seek EMA scientific opinion on suitability of companion diagnostic to medicinal product if the latter falls in scope of centralised procedure Falls in mandatory scope of centralised procedure.Notified body must seek EMA scientific opinion on quality, safety, and usefulness of ancillary medicinal substance if ancillary substance: Medical devices with an ancillary medicinal substance Medicines used in combination with a medical deviceĮMA assesses safety and effectiveness of medicines used in combination with medical device within centralised procedure application for medicinal product

Table 1: EMA regulatory responsibilities per medical device category Medical device category

Ema emr pain management