Medical devices have a significant role in protecting patients and public health. They assist in diagnosing preventing, monitoring, predicting, and treating illness.
Previously, medical devices had been subject to the EU Medical Device Directive (‘MDD’) (93/42/EEC). However, as of 26th May 2021 the MDD was replaced by the EU Medical Device Regulations (‘MDR’) (Regulation (EU) 2017/745). A recent extension to the transitional periods allows medical device companies further time to prepare for this change.
Overview of Regulation
The MDR expands upon the MDD to enhance healthcare by ensuring increased safety and performance requirements. To achieve this, the MDR encourages wider compliance by standardising medical device regulations throughout Europe and focuses on encouraging policies and procedures that enhance the responsibilities of medical device companies throughout the entire product life cycle. Noteworthy inclusions and expansion of the MDD by the MDR include:
The Regulation introduces a system whereby devices, manufacturers, importers, and authorised representatives are required to ensure traceability throughout the supply chain of a device from manufacture to implementation. Traceability information is recorded by a unique numeric or alphanumeric code (‘a Unique Device Identifier’) which ensures expeditious transfer of information to allow swift action where any issue arises.
The classification of medical devices according to intended purpose and inherent risks as set out in Annex VIII to the Regulation.
- Incident reporting
The Regulation introduces obligations for Member States to encourage and enable healthcare professionals, users and patients to report suspected incidents via standardised formats, above and beyond the existing obligations for manufacturers to report serious incidents and trends in non-serious incidents.
MDR implementation and transitional periods
Whilst the MDR has been in force since 26th May 2021, original transitional provisions allowed certain medical devices that are compliant with the MDD to remain on the EU market until 26th May 2024. However, owing to numerous factors, inclusive of the impact of Covid-19 and the possible risk of shortages of essential medical devices within the EU, the European Parliament voted to adopt EC proposals to extend the transitional periods and, on the 20th March 2023, Regulation (EU) 2023/607 became operational. This new implementing regulation extends the transitional periods of the MDR.
Depending on the device classification, transitional periods were extended to a specified date to ensure MDR compliance. In order to remain on the market after 2026, 2027 or 2028 respectively (classes identified below), any devices currently availing of these transitional provisions must be MDR compliant.
The timelines for the extension of the transition period are as follows:
26th May 2026
End of transition period for class III custom-made implantable devices (subject to compliance with certain requirements – see Regulation (EU) 2023/607 - amending Regulations (EU) 2017/745 and (EU) 2017/746.
31st December 2027
End of transition period for all class III devices, and for class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.
31st December 2028
End of transition period class IIb devices other than those covered by point (a) of this paragraph, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function.
31st December 2028
End of transition period for devices not requiring the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26th May 2021 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body
The extension only applies to devices which meet the criteria or conditions outlined in Regulation (EU) 2023/607. The following conditions are required to be met:
- Devices continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable;
- There are no significant changes in the design and intended purpose;
- The devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;
- No later than 26th May 2024, the manufacturer has put in place a quality management system in accordance with Article 10(9);
- No later than 26th May 2024, the manufacturer or the authorised representative has lodged a formal application with a notified body in accordance with Section 4.3, first subparagraph, of Annex VII for conformity assessment in respect of a device referred to in paragraph 3a or 3b of this Article or in respect of a device intended to substitute that device, and, no later than 26th September 2024, the notified body and the manufacturer have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII.
Whilst the transition periods have been extended to dates in 2026, 2027 and 2028 as set out above, manufacturers are obliged to take action in the immediate future to avail of the extended transitional periods:
By 26th May 2024 manufacturers are obliged to put in place a quality management system accordance with Article 10(9) (EU) 2017/745.
By 26th May 2024 manufacturers or an authorised representative are obliged to lodge a formal application with a notified body for conformity assessment in respect of a device referred to in paragraph 3a or 3b (EU) 2017/745 (as amended by Regulation (EU) 2023/607).
By 26th September 2024, in respect of a device intended to substitute that device the notified body and the manufacturer have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII.
While the MDR will create more harmony across the EU and assist with patient safety, there is clearly increased obligations on medical device companies. This will become more evident as further compliance requirements are fast approaching.Back to Full News
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About the Author
Stephen is a partner in the Healthcare team at Hayes solicitors. Stephen specialises in the defence of medical and dental negligence claims taken against hospitals as well as individual medical and dental practitioners.