Global Regulatory Pulse

European Commission Mandate for EU Parliament Negotiations on MDR delay: Clarification regarding Article 120(3)

In European Market, Regulatory by Matt Royle and Adrian Keene0 Comments

On 3 April 2020, NAMSA’s EU Regulatory experts provided a critique of The European Commission’s proposal to delay the date of MDR application by one year, found here. Crucially, there appeared to be a discrepancy between the proposed date of delay and Article 120 section 3, which itself was updated under the second corrigenda to the MDR in late 2019. The European Council has now issued a further document, which corrects the ambiguity identified previously in Article 120 (3).

Update
On 7 April, the European Council provided feedback regarding the European Commission’s proposal to delay the date of application of certain provisions of Regulation (EU) 2017/745 on Medical Devices (MDR) by one year to 26 May 2021 in light of the COVID-19 pandemic.

Key message for medical device manufacturers:

  • The proposed delay to the date of application of the MDR would apply to Article 120 section 3, which would allow manufacturers* additional opportunities to extend Medical Device Directive (MDD) certificates, make significant changes and changes to intended purpose, and more time to prepare their Quality Management Systems (QMS) to meet the stricter post-market surveillance, market surveillance, vigilance and arrangements with Economic Operators requirements.

*The extent to which the benefits of a one-year delay might be realised by manufacturers as discussed below.

Article 120 (3) describes the conditions that manufacturers must meet if they are to continue to place devices that meet Directive 93/42/EEC concerning medical devices (MDD) on the market after the date of application of the MDR (often referred to as the ‘grace period’). Within the original text of the MDR (published on 05 April 2017, and entered into force on 25 April 2017) described these  conditions applicable in regards to “… the date of application of this Regulation…”.

At that time, other Articles of the MDR stipulated that the date of application was 26 May 2020. However, Article 120 (3) was amended in late 2019 as a result of the second corrigenda (described as ‘C2’ in the consolidated version of the MDR.), where the date of application of the MDR now specifically states the conditions with a date of “…26 May 2020…”.

When the European Commission published their proposal to delay the date of application by one year, they did not include proposed changes to Article 120 (3), which led to some confusion. It was not clear whether the European Commission intended that the new date of application should be a ‘soft delay’, where Article 120 section 3 C2 conditions would still apply from 26 May 2020, or if the European Commission simply made an administrative error and overlooked an aspect of the second corrigenda.

The European Council have been quick to provide feedback on the proposed delay to the date of application of the MDR, and has provided clarification that the text of Article 120 section 3 C2 text should be updated to reflect the proposed delay (i.e. and state 26 May 2021).

The European Council have therefore updated the proposal to read:

  • “By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2021 it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.”

The European Council has therefore addressed the ambiguity, and makes it clear that the date of application would also apply to the ‘grace period’.

How might manufacturers benefit from the one year delay to the ‘grace period’?Notwithstanding the proposed delay of the date of application by one year, the extent to which the benefits of this delay might be realised by manufacturers are summarised below.

I. MDD Certificate Renewal

Under the ‘current’ date of application of the MDR of 26 May 2020, Notified Bodies have had capacity issues when trying to service all manufacturers’ requests to conduct ‘early’ MDD certificate renewals (such that audits and certificate issuance could be undertaken by 25 May 2020).

How will Notified Bodies use this additional one year if the date of application is extended to 26 May 2021? Each Notified Body will determine their own model on how to best use this additional time. Due to the self-isolation, social distancing, and general global lockdown due to COVID-19, the ability of Notified Bodies to conduct on-site renewal audits is significantly hindered, and will likely continue to be so over the coming months. It is recommended to review your MDR transition plan against your current MDD certificate expiry dates, and speak to your Notified Body on a case-by-case basis to understand whether they might be able to offer further MDD early renewal audits.

In addition, Notified Bodies will also be under significantly increased workload due to the immediate necessity to facilitate the supply medical devices to healthcare workers and patients in order to fight the COVID-19 pandemic. As such, Notified Bodies will likely need to divert some resource over the next 12 months (and as a result, have less resources available to conduct MDD certificate renewals) to support.

a. Current clients that manufacture essential medical devices (e.g. ventilators) where ramp-up of capacity might require conformity assessment of additional critical suppliers and/or sub-contractors to the MDD

b. New clients that wish to be the (legal) manufacturer of essential medical devices, which require conformity assessment to the MDD

II. MDD: Significant Changes

Under the current date of application of MDR of 26 May 2020, Notified Bodies have had capacity issues when trying to service all manufacturers’ requests to review applications to make significant changes prior to May 2020, after which no significant changes could be made. There have been reports that Notified Bodies have been prioritising early MDD certificate renewals over significant change reviews in order to allow as many manufactures as possible to benefit from the grace period.

How will Notified Bodies use this additional one year if the date of application is extended to 26 May 2021? Each Notified Body will determine their own model on how to best use this additional time. Due to the self-isolation, social distancing, and general global lockdown due to COVID-19, the ability of Notified Bodies to conduct on-site change audits (e.g. change in sterilisation vendor, or addition of a new supplier that provides a critical manufacturing step) is significantly hindered right now, and will likely continue to be so over the coming months. Alternatively, due to the travel restrictions in place, Notified Bodies will likely have additional resource available to conduct remote ‘desktop’ significant change assessments. Notified Bodies may prioritise those significant change requests already planned for, but there might be certain circumstances where your Notified Body might be prepared to conduct a significant change request that are identified following serious incidents, as opposed to non-urgent significant changes (such as range line extensions). It is recommended to speak to your Notified Body on a case-by-case basis to understand what criteria they will apply to review of significant changes prior to 26 May 2021.

In addition, Notified Bodies will be under significantly increased workloads due to the immediate necessity to facilitate the supply of medical devices to healthcare workers and patients in order to fight the COVID-19 pandemic.  As such, Notified Bodies will likely need to divert some resource over the next 12 months (and as a result have less resource available to conduct MDD significant change reviews) to support:

a. Current clients that manufacture essential medical devices (e.g. ventilators) where ramp-up of capacity might require conformity assessments of additional critical suppliers and/or sub-contractors to the MDD

b. New clients that wish to be the (legal) manufacturer of essential medical devices, which require conformity assessment to the MDD

III. Requirement to comply with MDR regarding Post-Market Surveillance, Market Surveillance, Vigilance, and registration of Economic Operators from the date of application

If ratified by the European Parliament, manufacturers will have an additional year before the requirements of Article 120 section 3 regarding Post-Market Surveillance, Market Surveillance, Vigilance, and registration of Economic Operators are mandatory. This is likely to be one of the major areas where a manufacturer will benefit from the proposed delay to the date of application to 26 May 2021. In particular, this will give manufacturers more time to understand their current Economic Operator relationships, and ensure that logistical issues are resolved and contracts put into place.

IV. Class I Devices

Under the current date of application of MDR of 26 May 2020, the second corrigenda of Article 120 section 3 clarified which class I devices would benefit from the ‘grace period’ until 26 May 2024 (i.e. those with an MDD Declaration of Conformity issued prior to 26 May 2020 and where a Notified Body is required under MDR). For example:

  • MDD class Im and Is = MDR class Im and Is
  • MDD class I = MDR (re-classified) class Ir
  • MDD class I = MDR (up-classified) class IIa/IIb/III

However, the class I devices that do not benefit from the grace period were:

  • MDD class I (self-certified) = MDR class I (self-certified)

This is likely to be one of the major areas where a manufacturer will benefit from the proposed delay to the date of application to 26 May 2021. Manufacturers of devices that remain class I only (i.e. not class Is, Im or Ir) under the MDR, would have an additional one year in which to ensure their self-certificated class I devices meet MDR requirements. 

V. More Notified Bodies designated to the MDR

At present, there are 12 Notified Bodies designated to the MDR (noting that BSI has two legal entities designated – UK and The Netherlands), despite that in June 2019 the European Commission stated that it expected a further 20 Notified Bodies to be designated by end of 2020 (Source: RAPS, 14 June 2019: May 2020 MDR Deadline is ‘Realistic and Achievable,’ EU Health Commissioner Says. Website accessed 12-Aug-2019).

Delaying the date of application of the MDR by one year to 26 May 2021 therefore gives additional time for Notified Bodies to achieve MDR designation. However, the true benefit to manufacturers will be in relation to how their Notified Body decides to use the one year delay to service their current clients under MDD (see sections I and II).

European Parliament is due to vote of the proposed changed on 16 Apr 2020
It is important to discuss the outcome of this vote with your Notified Body at the earliest opportunity, and understand how your business will make the most of the delay to the date of application of the MDR. It is also critical that senior leadership teams understand that it is not likely to be ‘MDD business as usual’ over the next 12 months, and that the extent to which each manufacturer will benefit will vary.

Conclusion
The European Council’s timely review and notable correction regarding the grace period to the European Commission’s proposal to delay the date of application until 26 May 2021 will likely be well received by all EU medical device stakeholders. However, the extent to which each manufacturer might benefit will be largely reliant on how their Notified Body decide to use this additional one year period.

Given the increased requirements of the MDR, this additional time will be well spent by manufacturers continuing to push forward their preparations for the date of application in May 2021. Simply put, it is not the time to put on the brakes.

How Can NAMSA Help?
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. Our internal teams of medical device development experts communicate with EU entities nearly every day and are the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers.

Additionally, NAMSA provides support to market authorization holders, including implementation of MDR requirements, MDR/IVDR conformity strategies and compilation of appropriate technical documentation for submission to Notified Bodies.

Learn more about NAMSA’s MDR resources here.

Authors:

Matt supports medical device clients worldwide to understand and meet the regulatory requirements in the EU. He has over 15 years’ experience in medical device research, product development and regulatory affairs. He has experience in start-ups, medium-sized and multinationals, bringing new products to market and supporting existing portfolios, and providing leading roles in advising and implementing EU regulatory strategy. He worked as a Notified Body Product Specialist for a number of years, specialising in conformity assessment of implantable class III and IIb orthopaedic joint replacement and sports medicine, spinal, and bone grafting devices, as well as associated class IIa instruments. Matt has a Master’s degree in Mechanical with Medical Engineering from University of Leeds, a PhD in orthopaedic biotriobology from Queen Mary, University of London, and is a Chartered Engineer with the Institution of Mechanical Engineers.

Adrian is Director of EMEA Consulting Services at NAMSA, where he utilizes his broad experience of changing EU medical device regulatory requirements to support clients worldwide. He is responsible for interpreting 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.

Leave a Comment