EU Medical Device Regulation: What does it mean for manufacturers?
April 6, 2020
Updated: On 24 April 2020, in the Official Journal of the European Union, the EMA confirmed a one-year postponement to the go-live date for the EU Medical Device Regulation and an extension of validity of the current Medical Device Directive. This measure comes just over a month before the regulation would have taken force, and almost exactly a month after the European Commission announced plans to introduce the delay in light of disruption resulting from the coronavirus pandemic. This means the EU Medical Device Regulation, originally scheduled to go into effect May 26, 2020, will now take effect on May 26, 2021.
What does the EU Medical Device Regulation mean for manufacturers? What steps need to be taken to deliver the robust post-market literature monitoring that will be needed? Is it time to review your literature searching arrangements?
Current European legislation ensures the safety and efficacy of medical devices and enables patients’ access to devices in the European market. But new EU regulations are due to come into effect between now and 2022 to replace the three existing directives. The new rules have been designed to keep up with continuing advances in science and technology; and have the aim of establishing a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety.
How will the new medical device regulation affect literature searching at your organisation?
The new regulation concerning medical devices (MDR 2017/745) will come into effect on 26th May, 2021. The update introduces stricter requirements for clinical data and the continuous process of clinical evaluation1. As such, there will be specific implications for literature searching:
– Reinforcement of the rules on clinical evidence (including an EU-wide coordinated procedure for authorising multi-centre clinical investigations);
– Strengthening of post-market surveillance requirements for manufacturers.
What does this mean?
In basic terms, it means the way you approach your research is going to change in two areas:
1. Search Strategy
‘Literature search protocols’ have been introduced to provide a plan for the search phase. To ensure compliance, your search strategy should be developed and implemented by information science professionals. Going forward, you will need to provide a description of the ‘search strategy protocol’ that you use to determine how articles are discovered, selected, and excluded. This will form an essential part of your submission documents. The protocol must include a description of your search resources and collate the search terms used (alongside the specific inclusion and exclusion criteria).
2. Database Selection
‘Clinical data’ provides information concerning the safety and/or performance of a device. This data should be sourced from the following channels:
– Clinical investigation(s) of the device concerned;
– Clinical investigation(s) or other studies reported in scientific literature2;
– Peer reviewed scientific literature3;
– Clinically relevant information derived from post-market surveillance – particularly clinical follow-ups4.
Within the new guideline revisions, Appendix A4 of MEDDEV 2.7/1 rev 4 identifies the appropriate literature databases to be used in research and highlights the different sources of clinical literature that can be searched during clinical evaluation. To stay within these updated guidelines, a comprehensive search strategy is essential, and will require access to multiple databases.
One of the main takeaways from the revision, is that coverage of European journals is not 100% complete within single scientific literature databases – so, whilst MEDLINE will provide a good starting point for your research, it should not be used as a definitive resource. Considerations should also be made to data presented at congresses; and citations referenced in scientific literature should also be screened for insights.
How can Dialog help?
Dialog offers our clients access to more than 140 databases for comprehensive searching across a wide range of authoritative sources. Using the Dialog Alerts Manager, you can create comprehensive, well-documented alert strategies, whilst maintaining an inspection-ready audit trail.
Database content on the Dialog platform is extensive and varied, and offers the following additional benefits:
– Wide coverage of literature relating to devices and therapies across Europe
– Simple searches, by device name and manufacturer
– Advanced searches, involving risks based on a case or a case series
We also have a search services team that can help create searches and alerts for your medical devices. This will ensure that you comply with the requirements of the new regulation.
If you’re a medical device manufacturer, we can help explain what the EU Medical Device Regulation means for you. And if you want to ensure you are regulation ready, get in touch to find out how Dialog Solutions can streamline and safeguard your research.
1. Clinical evaluation is defined as a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify its safety and performance of the device, when used as intended by the manufacturer.
2. Where equivalence to the device in question can be demonstrated.
3. On other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated.
4. These may not qualify for publication in high impact medical journals, low impact journals may therefore need to be searched.
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