MDD & MDR Dates
Let’s start with a quick summary of important MDD and MDR dates & timelines.
As you surely already know, after being postponed for a year due to the Covid pandemic, the MDR is applicable from 26 May 2021 – this date is called in the MDR jargon – Date of Application (DoA).
The manufacturers can still use the certificates issued by Notified Bodies under the Medical Devices Directive 93/42/EEC (MDD) and the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD). These certificates will be valid until the end of the period indicated on the certificate, which should not exceed five years from its issuance.
Finally, all MDD and AIMDD certificates will become void after 26 May 2024, and that is practically the last date for placing medical devices on the market. Devices placed on the market before 26 May 2024 may continue to be made available on the market or put into service until 26 May 2025.
What about Class I Devices?
Class I devices which under Regulation 2017/745 (MDR) would require Notified Body (e.g., re-usable surgical instruments or up-classified device), and which drew up the product Declaration of Conformity before 26 May 2021, under the MDD or AIMDD, may be placed on the market or put into service after the DoA of the MDR and no later than 26 May 2024 (or by the certificate expiry date, whichever comes first) transitional period. This transitional period is based on MDR article 120 and applies if the following conditions are met: devices must continue to comply with MDD and AIMDD, and there are no significant changes in the design and intended purpose after 26 May 2021.
Having this said, several MDR Requirements already apply after DoA, even for Class I devices that utilize the transitional provisions clause: post-market surveillance (PMS); market surveillance; vigilance; registration of economic operators, and registration of devices. We will try to shed more light on these MDR requirements in the coming posts.
What is a product significant change?
The manufacturers should carefully read MDCG 2020-3 – Guidance on significant changes regarding the transitional provision under Article 120 of the MDR concerning devices covered by certificates according to MDD or AIMDD.
As per Article 120 of MDR or Article 110 of Regulation 2017/746 (IVDR), we already mentioned that no significant changes in the design or intended device purpose are allowed after the DoA.
Implementing such a change would prevent the manufacturer from placing that device on the market under the Directives. In other words, such change would require upgrading certification from MDD/AIMDD to EU MDR.
Therefore, when considering any change in the product, the manufacturer should analyze whether such change may affect the design or the intended purpose of the device. In case of doubt, the manufacturer should consult their notified body. For, e.g., switching from the QMS documentation system, which contains paper (hardcopy) and to entirely electronic (paperless) records and signatures might be considered significant (as per NBOG 2014-3) but in some scenarios may not. The change of manufacturer, an importer, must be assessed on a case-to-case basis.
Product changes and QMS
The process of change assessment should be described in the company Quality Management System (QMS) and reflected in its relevant procedures such as:
- Strategy for regulatory compliance
- Reporting/notification of significant changes
- Notification procedure between the manufacturer and Notified Body
- Product configuration/engineering changes
- Change control
- Design control or
- Other methods, as applicable
MDCG 2020-3 guidance provides helpful flowcharts to facilitate a harmonized judgment of the significance of changes.
Intended use changes
- change of intended use or its extension (other than limitation),
- new patient/user population (other than more limited target population),
- change in clinical use (e.g., change in anatomical/access site)
Design/performance specification changes
- changes that require additional usability or clinical data to support performance or safety,
- occurrence of new risks which require mitigation or negatively impact existing risks,
- change in built-in controls,
- change in operating principle, mode of action, source of energy or alarms,
- changes that make a device more challenging to sterilize
- any changes to materials of human or animal origin,
- any changes to medicinal substances included in the product,
- new suppliers for product material or ingredient where the new specifications which do not meet existing ingredient specifications,
- sterilization changes, such as changes in sterilization method (including a shift from non-sterile to sterile status) or sterility assurance level,
- changes in a sterile device’s packaging design affecting functionality, safety, stability, or seal integrity
- changes of the operating system or any component,
- new or modified architecture/database structure/algorithm,
- user-input replaced by a closed-loop algorithm,
- new diagnostic/therapeutic feature,
- new channel of interoperability (e.g., exporting data from a device to the cloud),
- a new user interface,
- a new presentation of medical data (e.g., in a new format, dimension, or measuring unit)
Non-significant changes are changes that do not impact the design or the intended purpose of the device (as per the meaning of the MDR Article 120(3)). Thus, MDR allows the implementation of such a change during the transitional period.
Not requiring notification to Notified Bodies
Here are some examples of non-significant changes which doesn’t require notification to the Notified Body:
- administrative changes such as manufacturer’s name, address, or
- change of the Authorised Representative.
Requiring notification to Notified Bodies
Unlike administrative changes, the changes listed below would require notification to the Notified Body:
- relocation or addition of new manufacturing site (incl. for subcontractors and suppliers),
- changes to the quality management system, which does not affect the conformity assessment certification conditions,
- the change related to corrective actions that have been assessed and accepted by the relevant competent authority (even if they include significant for, e.g., design change)
The manufacturer should always prove that all the changes mentioned above do not affect the design or the intended purpose.
Verification of Changes
Non-Class I devices
Notified Bodies will verify changes and their implementation for devices other than Class I, at audits or upon change notification submissions. In addition, the Notified Body will determine whether an existing MDD/AIMDD certificate remains valid or there is a need for a new EU MDR certificate.
After reviewing the manufacturer’s description of the change, the notified body may confirm in writing that the implementation of the change does not represent a significant change in design or intended purpose under MDR Article 120(3) and that the related AIMDD or MDD certificate remains valid. Such written confirmation complements information on an existing certificate but does not represent the issuance of an updated certificate. In case of requests from authorities, the manufacturer should number such letters received from the notified body and submit them together with the certificate.
Class I devices
Manufacturers of Class I devices requiring Notified Body involvement under the EU MDR should document their decision and its rationale related to changes, keep them in their company documentation, and make them available to the competent authorities when requested.
BioReg Services & MDD-MDR transition
In one of our previous posts, we explained that it would be wise to start preparing for the MDR audit on time – see here why.
The manufacturer should use the transitional (grace) period to undertake an MDD to MDR gap analysis of the technical documentation for the product.
Most companies will need to work on their PMS plan, PMCF plan, PMS report and PMCF evaluation report. We described the basic requirements for each of these documents in our recent blog.
The clinical evaluations should be compliant with MEDDEV 2.7/1, rev. 4. Most companies will need to update their Clinical Evaluation plan and the Clinical Evaluation Report (CER). 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 blogs:
If you plan to write your Clinical Evaluation Report (CER) and don’t know how to start – we advise you to use our CER template, which could be easily customized to your product – see here.
If you wish to inquire about product classification, MDR significant changes, or any other issue – BioReg is here for you. Please feel free to schedule an MDR 1hour consulting session (discounted).
For companies that want to inquire about our services, please schedule a free MDR introductory consulting session.
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