June 23, 2020 Blog Post
Updates from the EU
Medical Devices Legislation
The adoption in April 2017 ofRegulation (EU) 2017/745 on Medical Devices(MDR) andRegulation (EU) 2017/746 on In-Vitro Diagnostic Devices(IVDR) changed the European legal framework for medical devices, introducing new responsibilities for EMA and fornational competent authorities. Both Regulations entered into force in May 2017 and have a staggered transitional period.
Update: On 23 April 2020, the European Parliament and the Council of the EU adopted a proposal to extend the transitional period of the Medical Devices Regulation by one year - until 26 May 2021.
This measure aims to avoid shortages of medical devices during the ongoing COVID-19 pandemic due to the limited capacity of national competent authorities or notified bodies to implement the Regulation.
EMA will update its regulatory guidance in June 2020 to reflect the new date of application of the Regulation.
For more information, see:
Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions
The MDR has a transitional period of four years and will fully apply from 26 May 2021. The IVDR has a transitional period of five years and will fully apply from 26 May 2022.
During the transitional period, manufacturers can opt to place medical devices on the market under the applicable EU Directives (93/42/EEC, 98/79/EC and 90/385/EEC) or under the new Regulations if they fully comply with these.
For guidance on the implementation of the new Regulations, see:
Medicinal products that include a medical device
Some medicines are used in combination with a medical device, usually to enable the delivery of the medicine.
If the principle intended action of the combination product is achieved by the medicine, the entire product is regulated as a medicinal product under Directive 2001/83/EC or Regulation (EC) No 726/2004.
There are two types of combination:
integral: the medicinal product and device form a single integrated product e.g. pre-filled syringes and pens, patches for transdermal drug delivery and pre-filled inhalers;
co-packaged: the medicinal product and the device are separate items contained in the same pack e.g. reusable pen for insulin cartridges, tablet delivery system with controller for pain management.
Medical devices that are co-packaged or obtained separately must be CE marked in accordance with the medical device legislation. Article 117 of the MDR introduced a new requirement for medicines with an integral device. From 26 May 2021, the marketing authorisation application should include a CE certificate for the device or, if it is not CE marked but would need to be certified if marketed separately, the applicant must include an opinion from a notified body on the conformity of the device. This requirement does not apply to Class I devices (non-sterile, non-measuring). For further information, see Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)
Role of EMA The Agency is responsible for evaluating the quality, safety and efficacy of marketing authorisation applications assessed through the centralised procedure, including the safety and performance of the medical device in relation to its use with the medicinal product. On 3 June 2019, EMA released for a 3-month public consultation a guideline on quality requirements for regulatory submissions for medicines that include a medical device (drug-device combinations). The device can be integral, co-packaged or obtained separately.
The guideline clarifies expectations laid down in Directive 2001/83/EC and addresses the new obligations in the MDR, in particular the requirements under Article 117. EMA will finalise the guideline in the second quarter of 2020.
Medical devices with an ancillary medicinal substance A 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. Examples of medical devices with an ancillary medicinal substance include drug-eluting stents, bone cement containing an antibiotic, catheters coated with heparin or an antibiotic agent and condoms coated with spermicides.
Role of EMA Before it can issue a CE certificate, the notified body must seek a scientific opinion from the Agency 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. For other substances, the notified body can seek the opinion from a national competent authority or EMA e.g. in cases where the Agency has already evaluated a medicine containing the same medicinal substance. EMA publishes consultation procedure public assessment reports (CPAR) on its scientific opinions. For information on the consultation procedure to seek an EMA scientific opinion, see Consultation procedure for ancillary medicinal substances in medical devices. Thoughts? Please comment below …
CEO and Principal Consultant
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