As EU medical device manufacturers and sponsors scramble to meet Medical Device Regulation (MDR) conformity in just six months, a second draft corrigenda was published on 25 November 2019 that implements many new proposed changes benefiting some EU device makers.
Although this document is yet to be finalized, there are significant scope changes that will positively impact MDR readiness plans for manufacturers of Class I devices. It also confirms the expectation that devices falling under the up-classification category, per MDR rules, will benefit from an extended period to meet full compliance and review by Notified Bodies.
To put these changes in context, provided below is further information regarding the impact of the draft corrigenda.
What Does the Second Corrigenda Mean?
While the current Medical Device Directive (MDD) only describes special requirements, such as Notified Body Involvement, for Class Im (m denotes measuring) and Class Is (s denotes sterile) devices, the MDR includes special requirements for Class Im, Is and now, Ir (r denotes reusable) devices.
In addition, some software previously classified as Class I under Rule 12 is being up-classified by the MDR.
- Article 120 of the second draft corrigenda stipulates that devices that meet the new definition of Class Ir do not need to be MDR complaint until 26 May 2024 (i.e. have undergone a Notified Body review and issued with a certificate).
- Therefore, these manufacturers will have until 2024 to meet MDR requirements for Class Ir for all current reusable surgical instruments.
- Any new Class Ir devices that manufacturers wish to develop and place on the market after 26 May 2020—or devices with significant changes to existing class Ir devices—will require compliance to the MDR. Thus, these devices will require a Notified Body assessment prior to sale in the EU after 26 May 2020.
- Similarly, software currently classified as a Class I device will also benefit from the Article 120 “grace” period to 26 May 2024.
What are Next Steps?
While the second corrigenda is currently in draft form, it will need to pass additional steps to be officially placed into law. It will require ratification by all 28 EU Member States, and will be voted on by the European Parliament. Early estimates project that this could be achieved by the end of 2019.
Although it is possible that the corrigenda could be blocked at any stage, passing it is a pragmatic solution to avoid the potentially very serious issue of surgical procedures performed after May 2020 (impacted by lack of availability of CE-marked reusable instruments). It also relieves some of the pressure on the limited number of Notified Bodies designated under the MDR who would need to issue CE certificates for all Class Ir devices prior to the date of application without the change (26 May 2020).
Comparison of Article 120 as Currently Published and Within the Draft Corrigenda
Current
3. By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation 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.
Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the certificate referred to in the first subparagraph shall continue to be responsible for the appropriate surveillance in respect of all of the applicable requirements relating to the devices it has certified.
Proposed
3. 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 2020and 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 2020it 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.
Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the certificate referred to in the first subparagraph shall continue to be responsible for the appropriate surveillance in respect of all of the applicable requirements relating to the devices it has certified.
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. NAMSA’s team of medical writers and regulatory specialists can provide full support to assist—in full, or partially-with SSCP activities.
Learn more about NAMSA’s MDR resources here.
Adrian Keene
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 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.