Regulation for medical devices: explanation of recent developments


Eamonn McGowran, medical device regulation specialist and associate director at global drug development consultancy, Boyds, explains the European Commission’s proposal to extend the transition period for Medical Device Regulation (MDR) and outlines the regulatory changes key that device and drug developers should be aware of. of.

At the Employment, Social Policy, Health and Consumer Affairs (EPSCO) meeting on December 9, 2022, the European Commissioner for Health and Safety, Stella Kyriakides, presented proposals in her opening speech to extend the transition rules of the Regulation of Medical Devices (EU) 2017/745.

The Medical Device Regulation (MDR) was adopted by the European Parliament and the Council in 2017. The Regulation states that medical devices can be placed on the EU market under CE certifications issued in accordance with Directive 93/42/EEC ( Medical Device Directive; MDD) or 90/385/EEC (Active Implantable Medical Device Directive; AIMDD) until May 26, 2024. After the transition period to the new rule, products require certification under the MDR.

Transition period

The transition period has been longer than originally anticipated due to several factors, including the pandemic and raw material shortages caused by the war in Ukraine, putting pressure on market readiness. According to the European Commission, notified bodies will have issued around 7,000 certificates under MDR by May 2024. However, there are 22,793 valid CE certificates issued under the above Directives and a considerable additional number of self-certified devices under MDD/AIMDD, which also require certification. The pressure on the system has caused several medical device manufacturers to withdraw their products from the market and take steps to reduce their product portfolio.

The transition deadline has been heavily criticized by politicians and industry stakeholders, with France, Ireland and Germany recently requesting an extension.

With patient safety at the forefront, the European Commission has reviewed its position and is proposing legislative measures to help prevent potential medical device shortages.

Commissioner Kyriakides proposed an amendment to the MDR to further extend the deadline for compliance with its provisions. This proposal will involve staggered timeframes extending through 2027, based on the risk classification of the devices. In addition, to avoid the discarding of safe medical devices, it is proposed to suppress the deadline of May 26, 2025 for the ‘sale’ of legally marketed products under the previous regulations.

On January 6, 2023, the European Commission published the proposal to extend the transitional provisions and, at the time of writing this report, it is in the European Parliament and the Council of the EU awaiting approval. If approved, the extension will help alleviate the challenges faced by medical device manufacturers seeking to accommodate new requirements under the MDR.

regulatory changes

There are new responsibilities for both developers and regulators with regard to drug-medical device combinations.

In Europe, the new Medical Device Regulation (EU) 2017/745, (EU MDR) and in vitro The Diagnostic Medical Device Regulation (EU) 2017/746 (EU IVDR) includes provisions regarding the responsibilities of the European Medicines Agency (EMA), National Competent Authorities (NCA) for medicines and medical devices, and Notified Bodies (NB), with regard to combinations of medicines with medical devices.

Some drugs are used in combination with a medical device, usually to allow delivery of the drug. When the drug achieves the primary intended action, it will be considered a drug that includes a medical device. Under the EU MDR regulations (article 117) for medical devices that form an integral product with a drug, there is a requirement to provide a CE certificate for the device. If it does not have the CE mark, the applicant must include an opinion of a NB on the conformity of the device.

In some cases, a medical device may contain an auxiliary medicinal substance to support the proper functioning of the device. These products are governed by medical device legislation and must be CE certified. In such cases, the EU MDR regulations (article 1(8)) require notified bodies to seek a scientific opinion from the NCA or EMA (if a medicinal product falls exclusively within the scope of the centralized procedure, or incorporates blood human or plasma-derived). Similarly, for medical devices composed of substances, or combinations of substances, that are systemically absorbed by the body to achieve their intended purpose, the NB will need to request a scientific opinion from an NCA or the EMA (EU MDR Article 52(11) ).

In addition, as part of the new EU IVDR, there are actions for complementary diagnostics (CDx). Such devices support the safe and effective use of a specific medication by identifying patients who are suitable or unsuitable for treatment. A new classification system has been introduced for CDx, together with the obligation to undergo a conformity assessment by an NB. Before the notified body can issue a CE certificate, the NB must request a scientific opinion from an NCA or the EMA on the suitability of the companion diagnostic for the medicinal product in question.

It is important that drug and device developers are aware of these new requirements and plan for relevant interactions in their regulatory strategies. Companies unsure of the changes should seek external regulatory affairs support and expertise to ensure full compliance with legislation and avoid further disruption to development timelines.


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