Author: Dr. Suzanne Broussard
The European Parliament adopted a Second Corrigendum of MDR 2017/745 to address the serious possibility for shortages of reusable class I medical devices under the newest Medical Devices Regulation (MDR) 2017/745.
The Second Corrigendum has significant scope changes that benefit class I devices falling under the up classification of the MDR 2017/745 rules. This is significant because as much as 80% of devices designated as class I under MDD will be “up classified,” e.g., moved from class I to a class II or even a class III designation, under MDR, and therefore face major hurdles and Notified Body (NB) approval to be marketed in the European Union. Thus, understanding and maintaining compliance under these dynamic regulations can be quite a balancing act.
Under the MDR, some class I devices are given a grace period until 26 May 2024 to be fully compliant. Article 120 section 3 of the Second Corrigenda clarifies which class I devices can benefit from the grace period.
Class I Devices eligible for the 4–year (now 3-year) grace period:
- Class I reusable surgical devices
- Many substance-based devices
- Software that will be up classified
Devices that are not eligible for the grace period:
- Devices that are class I self-certified under MDD at the time of MDR application
- Class I devices that are not up classified and will not need a NB
- Class I devices that have significant changes made in the design or intended use under the MDD certification once MDR is full force.
- Any new class I devices that manufacturers develop and place on the market after 25 May 2021.
NBs and manufacturers have been working overtime to get as many class I devices into the grace periods as possible. Manufacturers able to obtain MDD certification by the MDR date of application will have the significant benefit of the grace period to become compliant with MDR. The original MDR date of application provides a 4-year grace period. However, the 26 May 2020 deadline has been extended to 26 May 2021 due to the global COVID-19 pandemic. The deadline for class I device to be MDR compliant remains 26 May 2024, leaving manufacturers a 3-year grace period. Indeed, the recent 1-year extension for compliance with MDR 2017/745 will likely be used the most by manufacturers pushing to get their class I devices certified under MDD, and to ensure that the self-certification class I devices meet the MDR requirements.
The grace period for class I devices was incorporated to address the potentially very serious issue of lack of availability of CE-marked reusable instruments. However, the Second Corrigendum contains more than just an extension of the transitional period for certain products in class I according to MDD, it also deals with data from the pre-and post-market phases of medical devices, and registration of products according to MDD and MDR. See the entire document for the details (English pg 43-49).
In addition to providing some breathing room for manufacturers, this legally binding force takes some pressure off the few NBs currently designated under MDR to issue CE certificates as is required for all class I devices that up classify under the MDR.
Manufacturers need to understand that most of the MDR requirements will still apply to the class I devices, and that the grace period is not a delay in the application of MDR. This means that manufacturers must still set up quality management systems and procedures for post-market surveillance (PMS)/ post-market clinical follow-up (PMSF) and procedures for clinical evaluation and risk management.
Once the class I devices need to transfer to MDR CE certification, there will be more stringent requirements for clinical data. Fortunately, the extension when used effectively will provide manufacturers the clinical data needed to smoothly make the transition. The grace period essentially gives device manufacturers the opportunity to collect real-life data that can then be used as clinical evidence for the use of the device as they put in place the PMS, PMCF, and clinical evaluation.
MDR Article 120.3 as it reads with Second Corrigendum
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 2020 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 2020 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.
It will still be challenging for device manufacturers to effectively organize and compile the technical documents required under MDR 2017/745. Criterion Edges offers a team of experienced medical writers that can assist your internal teams in any capacity, in preparing for the MDD to MDR transition.