Global Regulatory Pulse

EU Commission & MDCG Release New MDR & IVDR Guidance Documents

In Consulting, European Market, Regulatory by Adrian Keene

The first half of October experienced a (small) flurry of activity from key stakeholders implementing the European Union’s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). In addition, useful templates for Field Safety Notices (FSN) under the existing EU Directives (Active Implantable Medical Devices Directive [AIMDD], Medical Device Directive [MDD] and In Vitro Diagnostic Directive [IVDD]) were published.

Explained below are these newly- released documents and links to access this information. You may also access NAMSA’s MDR/IVDR resources by clicking here.

I. MDR & IVDR Implementing Measures Rolling Plan

This document provides insight into both the progress to date on implementing acts, as well as planned activities moving forward. The key takeaway messages are:

a. Do not expect any implementing acts to be issued in 2018.

b. Reprocessing: The implementing act addressing reprocessing (Article 17(5)) has an expected timeline of November 2019, only six (6) months before the full date of application of the MDR, however the EU Commission is already highlighting that in the absence of this document, reprocessing will be performed according to harmonised standards and member state provisions. This may suggest a concern related to the timeline and whether it will be achieved.

c. Products without Medical Purpose: The implementing act (Article 9(1)) may allow for common specifications to be issued November 2019 – or six (6) months before the date of full application of the MDR. Informal consultation with Competent Authorities (CA) and stakeholders is expected to start in Q3.

d. Expert Panels: The designation of expert panels (Article 106(1)) is not likely to occur until July-September 2019, and presumably experts will then be allocated to the panels; a survey of MDCG and stakeholders is ongoing. It appears unlikely that any devices requiring pre-market scrutiny under MDR will be able to undergo expert panel review until – at the earliest – Q4 2019, therefore Notified Bodies (NB) may feasibly get designated in Q2 2019, but won’t be able to fulfil their requirements of pre-market scrutiny until the expert panels are operational.

e. Expert Laboratories: The designation of expert laboratories (Article 106(7)) is not seen as a priority, and will likely occur after the date of application (26 May 2020).

f. Expert Panel Fees: The definition of fees for expert panels (Article 106(13)), which are needed by both NBs and manufacturers so that budgets can be planned, will not be available until Q4 2019 (perhaps six [6] months before the date of application).

g. UDI: The implementing act (Article 27(2)) designating the entity(ies) to operate the assignment of UDIs will not occur until May 2019, with a call for entities to apply in Q4 2018.

h. EUDAMED: The implementing act (Article 33(8)) addressing detailed arrangements for set up and maintenance is ongoing with a target for completion Q4 2019.

Access more information here.

II. Other Actions & Initiatives

a. Designation of NBs is ongoing and the EU Commission states that the “full scope of MDR and IVDR [is] covered,” however, that doesn’t necessarily mean that one NB will hold such a complete scope. It is therefore possible that manufacturers may need multiple NBs to fulfil their scope of certification. The EU Commission also released an updated presentation entitled: “State-of-Play of Joint Assessments of Notified Bodies in the Medical Device Sector,” accessible here, which shows that there have been 33 applications for designation (26 MDR, 7 IVDR) with 11 on-site audits performed through September and an additional 11 scheduled up to January 2019. Two (2) NBs have so far as to provide CAPA plans via their CA, but no designating authority final reports have been received by the EU Commission (indicating designation of any NB is not likely in the near future).

b. There is plenty of activity associated with EUDAMED, with the likely date of “go-live” set as 25 March 2020. Further documents have been issued by the MDCG this month (see below).

c. The EU Commission recognises the need for a communications campaign following the issuing of the first “fact sheets” in July 2018, 15 months after the MDR was published in the Official Journal of the European Union. Additional factsheets are expected Q4 2018.

d. The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) will publish their opinion on Phthalates mid-2019.

e. There is an ongoing discussion with member states on the mandate for European Standards Organisations to develop standards harmonised with the MDR, with the first mandate in Q1 2019. This means it is unlikely that any harmonised standards, i.e. those containing an annex Z that equates the standard to the relevant part of the MDR, will be available in the near future.

III. Field Safety Notice (FSN) Templates

A Q&A document, as well as templates for FSN actions under the existing directives, have been issued – these provide valuable guidance for manufacturers. These include:

  • Field Safety Notice
  • Field Safety Notice – Customer Reply
  • Field Safety Notice Distributor/Importer Reply
  • Questions and Answers to fill in the Field Safety Notice
    • (Documents date: 10/10/2018 – Created by GROW.DDGI. D.4)

Please click here to access.

IV. Further Guidance from MDCG on UDI

The MDCG published five (5) documents that provide further information related to UDI: systems and procedure packs; UDI for software; UDI where importers, distributors of others undertake the obligation of manufacturers; and language expectations. These documents are entitled:

  • MDCG 2018-3: Guidance on UDI for systems and procedure packs (October 2018)
  • MDCG 2018-4: Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs (October 2018)
  • MDCGT 2018-5: UDI Assignment to Medical Device Software (October 2018)
  • MDCG 2018-6: Clarifications of UDI related responsibilities in relation to Article 16 (October 2018)
  • MDCG 2018-7: Provisional considerations regarding language issues (published October 2018)

Please click here to access.

Summary
Although these new publications are welcomed, the implementing measures rolling plan, with its apparent focus on completing actions 6 months prior to the date of application in May 2020, reminds us that manufacturers cannot afford to await guidance documents, and must act now using the best guidance and expertise available to prepare for MDR implementation..

Although it may be necessary to make adjustments “on the fly” as new information becomes available, it is unlikely that manufacturers will be penalised for being proactive. However, intransigence at this time will likely result in significant challenges in maintaining access to the EU medical device market in 2020 and beyond.

How can NAMSA Help?
Navigating the international regulatory landscape can be overwhelming for any medical device manufacturer. That’s why having the right partner, at the right time, can be invaluable in achieving reimbursement requirements and market success.

NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. In fact, our internal teams of medical device development experts communicate with EU entities nearly every day. Our teams are the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers. This expertise has been proven to save medical device organizations up to $17M in costs and 23 months in development timelines (access our client testimonials here). Additionally

If you are interested in speaking with us about EU-related activities or other global regulatory strategies, please contact us at: communications@namsa.com or 1-419-666-9455. You may also visit our regulatory consulting webpage here.

Authors:

Adrian is Director of Product Development Strategy at NAMSA, where he utilizes his broad experience of changing EU medical device regulatory requirements to support clients worldwide. He is responsible for new product development using EU regulatory requirements to provide a balanced interpretation of the needs and expectations of both competent authorities and manufacturers. He works with a broad range of devices including drug-device combination products. Adrian previously Head of Notified Body of SGS in the UK, and also served as the Global Clinical Affairs and Regulatory Manager for Medical Devices (SGS) with responsibility for conformity assessment activities of high-risk (Class III) devices under the Medical Devices Directive (MDD). In all, Adrian has 25 years’ experience in the medical device industry. He attended the School of Pharmacy at the University of London following and conducted postgraduate research in “Retinoid-Induced Skeletal Toxicity.” He also holds a diploma in “Managing Medical Product Innovation” from the Scandinavian International Management Institute.