Guest Column | July 8, 2020

Implications Of COVID-19: EU MDR Implementation Update

By Marcelo Trevino, President, Global Regulatory Affairs and Quality Systems, TregMedical

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The European Union Medical Device Regulation (EU MDR) issued in May 2017 had contemplated a three-year transition period that would have ended May 26, 2020. After this time, a four-year “soft” transition period would have allowed organizations to continue using their existing MDD certificates through May 26, 2024.

However, the COVID-19 pandemic has placed a tremendous burden on the medical device industry — particularly the increased demand for devices like intensive care equipment, medical-grade masks, gloves, and other personal protective equipment (PPE). As a result, an MDR amendment1 published by the European Commission in April 2020 altered certain MDR provisions’ dates of application (DoA).

While the medical device industry eagerly expected this postponement, it is important to note the delay only applies to the MDR DoA — pushing it back one year to May 26, 2021 — and not to the soft transition period (MDD and AIMDD Certificates still expire May 27, 2024) or the sell-off period (organizations may continue placing MDD-cleared devices on the market until May 27, 2025).

MDR Article 59 is Immediately Applicable

As part of this amendment, Article 59 has been modified to postpone the application of the MDR and to free up resources to address COVID-19 issues by allowing individual Member States to authorize medical devices without a CE mark in their respective territories if there is a public health or a patient safety interest. The Commission may extend individual Member States’ decisions to authorize the use of non-CE marked devices across the rest of the EU.

Article 59.1 allows derogation from Conformity Assessment per a) MDR Article 52, b) AIMDD, Article 9 (1) and (2), and c) MDD Article 11 (1-6). The derogations replace measure provisions from AIMDD Article 9(9) and MDD Article 11(13).  As this is applied at a national level, national derogation decisions could vary from one member state to another. Article 59.1 clearance also depends on competent authority policies and evidence provided by the medical device manufacturer.

The EU Commission considers several factors prior to issuing a derogation decision, including the availability of device substitutes in the market, device criticality for health protection, compliance with harmonized standards and essential requirements, results of reports or tests performed by notified bodies (NBs), and market surveillance data. The current situation is impacting many manufacturers who, in response to the COVID-19 pandemic, currently are seeking or will seek derogations for their products at the EU Member State level. 

MCDG 2020-4: Notified Body Audits During COVID-19 Quarantine Orders and Travel Restrictions

As another consequence of the pandemic, onsite NB audits have not been feasible due to quarantine and travel restrictions. The Medical Device Coordination Group (MCDG) — comprising representatives of all Member States and chaired by a representative from the EU Commission — issued document MDCG 2020-4 to provide guidance2 on this topic. The guidance provides parameters under which temporary extraordinary measures can be applied, as well as empowers NBs to apply the guidance on a case-by-case basis using a risk-based approach, particularly where devices are considered relevant to medical care (especially if clinically necessary during the COVID-19 restrictions).

To clarify what constitutes “clinically necessary,” the EU Commission partnered with the World Health Organization (WHO) to provide a list of priority medical devices in the context of COVID-19. As of late June 2020, the list3 includes: 

  • Monitoring equipment
  • Oxygen therapy equipment and accessories
  • Airway Management and Intubation
  • Mechanical and Non-Invasive Ventilation equipment and accessories
  • ICU equipment and accessories
  • Imaging Equipment and accessories
  • Personal Protective Equipment

Depending on the manufacturer’s compliance history, NBs can determine whether remote audits can be conducted, to be supplemented with an onsite audit once travel restrictions are lifted. The NBs need to consider whether each organization has the infrastructure to conduct these assessments remotely— for example, adequate IT tools, data protection, and cybersecurity procedures.

The guidance, effective April 8, 2020, is applicable to surveillance audits, audits conducted for re-certification purposes, change notifications to notified bodies, and when an NB contract has been terminated so the manufacturer can to enter into a contract with another NB. The guidance may be applied may to unannounced audits, or when a special implementation of corrective measures is needed due to doubt around a device’s regulatory conformity, but it would not be permissible for initial certification audits or for audits where the certification scope requires extension.

Update on Guidance Documents

To ensure common understanding of the new regulations, several task forces have been tasked with developing guidance documents, overseen by the NBs. This work remains in progress, but several documents have already been endorsed:

 

Reference

Title

Publication

MDCG 2020-12

Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product, and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissues

June 2020

MDCG 2020-11

Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/2013

May 2020

MDCG 2020-10/1

MDCG 2020-10/2

Guidance on safety reporting in clinical investigations

Appendix: Clinical investigation summary safety report form

May2020

May 2020

MDCG 2020-4

Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions

April 2020

MDCG 2020-8

Guidance on PMCF evaluation report template

April 2020

MDCG 2020-7

Guidance on PMCF plan template

April 2020

MDCG 2020-6

Guidance on sufficient clinical evidence for legacy devices

April 2020

MDCG 2020-5

Guidance on clinical evaluation – Equivalence

April 2020

MDCG 2020-9

Regulatory requirements for ventilators and related accessories

April 2020

MDCG 2019-3 rev.1

Interpretation of article 54(2)b

April 2020

MDCG 2020-3

Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD

March 2020

MDCG 2020-1

Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software

March 2020

MDCG 2019-14

Explanatory note on MDR codes

December 2019

MDCG 2019-13

Guidance on sampling of devices for the assessment of the technical documentation

December 2019

MDCG 2019-16

Guidance on cybersecurity for medical devices

December 2019

MDCG 2019-11

Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746

October 2019

MDCG 2019-9

Summary of safety and clinical performance

August 2019

 

Documents clarifying “Common Specifications on Annex XVI products” (devices without medical purposes) and “Reprocessing of Single-Use Devices” are expected soon.

Update on Expert Panels

Hundreds of experts have been identified and are under review by MDCG. It is expected that they will be appointed in late July 2020, after which panels will begin to be structured. In the absence of Expert Panels, devices requiring a Clinical Evaluation Consultation to reach market under MDR will most likely be delayed until May 26, 2021. Additionally, a guidance evaluating risk/benefit profiles, intended to assist Expert Panels in issuing scientific opinions, is expected soon.

To date, 11 Expert Panels have been identified4 by EU 2019/1396:

1) Orthopedics, traumatology, rehabilitation, rheumatology

2) Circulatory system

3) Neurology

4) Respiratory system, anesthesiology, intensive care

5) Endocrinology and diabetes

6) General and plastic surgery and dentistry

7) Obstetrics and gynecology, including reproductive medicine

8) Gastroenterology and hepatology

9) Nephrology and urology

10) Ophthalmology

11) In-vitro diagnostic medical devices (IVD)

Update on the European Databank on Medical Devices (EUDAMED)

While the Commission hasn’t clarified when economic operators should expect the database to be functional, there was an indication in December 2019 that it will go live at the same time IVDR takes effect: May 26, 2022. This has been somewhat confusing, since the timeline for publication of the notice confirming EUDAMED is fully functioning under Article 34.1 has been pushed back to March 25, 2021, and it is expected that the module on actor registration will be deployed in March 2021. The module on UDI/device registration will be the second deployed, followed by the module on Certificates and Notified Bodies (May 2021).

The Commission still plans to sequentially deploy EUDAMED modules for voluntary use but a guidance addressing contingency measures in absence of EUDAMED by the DoA, as well as a Fact Sheet on information available to the public, remain in progress.

Conclusion

The COVID-19 pandemic has required medtech manufacturers to make quick adjustments in reacting to the medical device regulatory environment, particularly in managing implementation steps outlined in MDR 2017/745 and IVDR 2017/746. Many NBs are still going through the MDR Designation process and it is unknown if current events could negatively impact that process. Notified Bodies that obtained MDR designation in 2019 will need to be re-designated in 2022.

This, in addition to the fact that many medical device companies renewed their MDD and AIMD Certificates early, and by doing so pushed their MDR transition dates to 2024, will likely create a bottleneck in resources that manufacturers and NBs should take into account now.

Medical Device Periodic Safety Update Reports (PSUR) required by MDR for many types of devices will have to be submitted by manufacturers for NB review starting in May 2022, adding to the workload for both manufacturers and Notified Bodies. Additionally, many NBs and organizations must continue monitoring developments in the renewal of Mutual Recognition Agreements between EU and Switzerland, plus the EU and Turkey, each set to expire in May 2021.

Other organizations are still awaiting guidelines from the UK MHRA on the impact Brexit will have in the commercialization of medical devices — an endeavor that will likely require additional resource planning.

While medical device manufacturers have an extra year to comply with MDR, there are no changes in end dates; therefore, a grace period mechanism after May 2024 has not been contemplated. In-vitro diagnostic device companies should keep in mind this delay does not impact the IVDR DoA, which remains May 26, 2022.

Manufacturers should use this extra time to complete changes that could impact transition to MDR and consider that NBs already possessing designation have limited capacity and now also have to adhere to travel restrictions. During this transition, medical devices still need to comply with applicable MDD and AIMD rules, which remain in effect through next May.

Ultimately, the MDR delay presents a good opportunity for organizations plan changes or improvements to their quality management system (QMS), allowing for a smooth MDR transition, and to update contracts with suppliers to reflect any new responsibilities and timelines affected by these changes.

References

  1. EU 2020/561, amending regulation EU 2017/745. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2020.130.01.0018.01.ENG
  2. MCDG 2020-4: Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions https://ec.europa.eu/docsroom/documents/40705
  3. World Health Organization : https://www.who.int/publications/m/item/list-of-priority-medical-devices-for-covid-19-case-management
  4. EU 2019/1396 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2019.234.01.0023.01.ENG&toc=OJ:L:2019:234:TOC#:~:text=Commission%20Implementing%20Decision%20(EU)%202019,(Text%20with%20EEA%20relevance.)