As manufacturers of medical devices and sponsors struggle to meet MDR conformity, a second MDR amendment published at the end of 2019 may benefit some EU device manufacturers.
In this blog we want to summarize what the MDR grace period is and provide easy guidelines which will help you to determine which changes will be considered as significant changes.
”MDR grace” period – explanation
In November 2019, the Council of the European Union published a second amendment to the MDR – Medical Devices and In Vitro Diagnostic Medical Devices Regulations (see here https://data.consilium.europa.eu/doc/document/ST-13081-2019-INIT/en/pdf).
The most important change is introduced to MDR Article 120.3 which will now 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 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.
This change means that self-certified Class I medical devices under MDD which will be up-classified under the new MDR will not have to be certified to the new MDR from the Date of Application (May 26th, 2020). Instead, these may continue to rely on the Declaration of Conformity drawn up under the MDD until May 25th 2024.
Some groups of devices that may make use of this exemption include:
- Reusable surgical instruments
- Software that will be up classified
- Substance-based devices and any others
Please note that Class I medical devices that are not upgraded and will not need a Notified Body under MDR (self-certified) cannot make use of this exemption and they should apply using the new MDR EU from May 26th, 2020.
What is a significant change in light of MDR Article 120.3?
As stated in the regulation, the grace period can be used if, from the Date of Application, the product continues to comply with previous Directives (90/385/EEC or 93/42/EEC) and there are no significant changes in the product design and its intended purpose.
A significant change in the design or intended purpose of a device after the date of application of the MDR may prevent the manufacturer from marketing the device until compliance with the MDR is achieved.
It is therefore of the utmost importance for manufacturers to understand what “significant change” in this context means and to plan their activities accordingly.
MDD and AIMDD certificates will remain valid following changes that are not significant or unrelated to design or intended purpose.
All manufacturers, regardless of the class of their products should evaluate product changes relating to five main areas of concern:
- Change of intended purpose
- Change of design or performance specifications
- Change relating to a substance or material
- Change in sterilization method or device or packaging design which may impact sterilization
- Software changes
Let’s analyze which changes may fall under these areas.
Changes of intended purpose
- Any change of the intended purpose or patient population unless it is limiting in scope.
- Any new way of clinical application for the device
Changes in design or performance specifications
- Change in built-in control mechanism, operating principles, source of energy or alarms
- Change which affect the safety, performance or usability of the device when additional clinical or usability data are necessary to support safety and performance of the altered device
- Changes which introduce new hazards or negatively affect existing hazards
Changes related to ingredient or material
- Change to a material of human or animal origin
- Change to a material which contains a medicinal substance
- Change of ingredient or material from existing or new supplier which does not meet existing ingredient specifications, and which is in contact with patient tissue or fluid > 30 days or absorbed
Changes related to sterilization
- Change from sterile to non-sterile product
- Change of terminal sterilization method (includes change from non-sterile to sterile)
- Design changes which makes the device more difficult to sterilize
- Change in packaging which affects functionality, safety, stability or seal integrity
- Shelf-life change validated by using non-approved protocols or methods
Significant software changes
- New or major change of operating system
- New or modified architecture or database structure, change of an algorithm
- Required used input replaced by closed loop algorithm
- New feature of new channel of inter-operability
- New user interface or presentation of data
In summary, from May 26th, 2020 (Date of Application), manufacturers may not implement any significant change(s) to their devices if they place their products on the market under the MDD.
Manufacturers who wish or need to make significant changes after the Date of Application will need to obtain a certificate of conformity under the new EU MDR in order to continue to market the device.
Please note that all design changes relating to a Field Safety Corrective Action (FSCA) which have been assessed and accepted by the Competent Authority will not be considered “significant” in accordance with article 120 (MDR).
We recommend that you analyze each planned change and document your decision regarding the “significant” or “non-significant” status of the change.
You may consult additional regulatory guidelines which discuss significant and non-significant changes such as:
- Joint Industry Position on Significant Changes According to MDR Article 120(3) February 2019 (which this blog is based on)
- NBOG_BPG_2014_3 Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System and others
This blog is heavily based on these guidelines.
Other organizational or quality changes
Variations such as changes of manufacturer, manufacturing site, distributors and suppliers or quality management system may impact upon or consequently affect the design or intended purpose of the device. These and other changes should be internally evaluated and, if required, discussed with a regulatory or quality expert and responsible Authorized Representative.
New MDR requirements that apply from May 26th, 2020
We want to remind Class I self-certified companies that new MDR requirements relating to post-market surveillance, market surveillance, vigilance and the registration of economic operators and devices will apply from May 26th, 2020 regardless of whether they qualify for and make use of additional grace period exemption or not.
In addition, informed by experienced Authorized Representative, mdi Europa (https://mdi-europa.com/), it is expected that competent authorities will require improvements to the technical documentation for all exempt Class I products. We thus recommend that you review your product documentation before May 26, 2020 and discuss any required update with your regulatory advisor and your Authorized Representative.
Use Your Time Cleverly
You should use this grace period cleverly. We advise you to undertake a MDD to MDR gap analysis of the technical documentation for each of your products. Once you understand what gaps exist, you can begin to address these.
Most companies will need to work on their PMS plan, PMCF plan, PMS report and PMCF evaluation report. We described the basics requirements for each of these documents in one of our recent blogs.
In addition, clinical evaluations are expected to be undertaken in accordance with MEDDEV 2.7/1, rev. 4; it is anticipated that both the Clinical Evaluation plan and the Clinical Evaluation Report will need to be upgraded.
Manufacturers of up-classified devices now have the opportunity to collect real-life data from the use of their devices and use that information as clinical evidence.
For a full explanation of the clinical evaluation procedure, please refer to our previous blog: Medical device clinical evaluation according to new MDR Medical Device Regulation.
Please feel free to contact us (email@example.com) if you wish to inquire whether your Class I product will be up-classified, whether your planned change is significant or if you need any other help such as MDD-MDR gap analysis, PMS – PMCF plans or Clinical Evaluation Reports (CER).
Stay safe and healthy,