The European Council, the European body defining the general directions of the EU policy, recently announced they have published the draft of the second corrigendum to the Medical Devices Regulation (MDR) 2017/745.
Proposed Changes to the MDR
The most important amendments included in the Corrigendum are related to Class I medical devices. Class I is the lowest classification level in the risk-based classification system. Most of the Class I medical devices are non-invasive and sometimes even could be used safely without any additional instructions. This category includes a wide range of various devices, such as:
- Devices used to immobilize body parts,
- Devices for general external patient support,
- Devices for temporary storing,
- Devices intended for administering medicines,
- Devices intended to be used as a mechanical barrier (e.g. wound dressings),
- Handheld devices intended for transient use,
- Active medical devices other than classified under higher risk categories (such as lightning or general support devices).
According to the Proposed Changes:
- The device could be defined as a Class I medical device in accordance with the Directive 93/42/EEC (an EU regulation on medical devices replaced by the Regulation 2017/745 (MDR),
- There is a declaration of conformity provided before May 26, 2020, and
- The conformity assessment procedure requires the involvement of the notified body, or
- There is a valid certificate issued previously,
any of the above devices could be placed on the market until May 26, 2024. This means that manufacturers producing devices that fit the requirements listed hereabove will have four more years to gain compliance with the new requirements provided by the MDR while still being able to market their devices without committing additional actions and procedures. In other words, the period medical device manufacturers have to prepare the submission documents and materials would be extended substantially.
Besides these amendments, the Corrigendum contains a list of minor changes and corrections, such as changes and replacements in references to the articles and particular paragraphs and provisions.
MDR Implementation Delays
The changes proposed by the Corrigendum would probably reduce the number of low-risk applications notified bodies will have to deal with. Since there are only a few notified bodies already designated, the huge flow of such submissions could result in overload in the workflow of notified bodies, leading to delays in evaluation and even on the availability of such devices at the market. The implementation of such temporary exemption will allow notified bodies to focus on the most complicated high-risk medical devices while low-risk medical devices that are in compliance with the Directive 93/42/EEC would still be present at the market and thus available for patients and healthcare facilities.
However, it is not the only delay related to the implementation of the new framework to expect. As was reported previously earlier within the year, the implementation of Eudamed, the new medical device database, will be delayed too.
The European Commission also extended the application period for expert panels, the important advisory bodies that will have to provide notified bodies with scientific and technical support in the most complicated cases.
All these facts confirm that the system provided under the MDR is not ready to deal with all issues it will face after the regulation will be fully implemented. According to the statement published by MedTech Europe, the European medical technology association, the implementation process is slower than expected despite the efforts paid by all parties involved. It also warns about the same situation related to the In Vitro Diagnostic medical devices.
At the same time, there was no “grace period” provided for Class I medical devices. A “grace period” allows manufacturers to reschedule the obligatory recertification under MDR for a year. Such a special regime has been already introduced for particular categories of high-risk medical devices. After the implementation of the Corrigendum, similar rules will be also applicable to low-risk medical devices.
It is also important to mention that to be able to benefit from the proposed changes, medical device manufacturers have to pay attention to the following aspects:
- It is necessary to maintain compliance with the initial requirements set forth by the Directive 93/42/EEC,
- The construction, elements and intended purpose of the device should remain the same as provided in the existing declaration of conformity,
- Other requirements provided by the Regulation 2017/745 should be applied, including the requirements on post-marketing surveillance, maintenance, adverse events reporting and appointment of authorized representatives.
Corrigendum Implementation and Amendment Procedures
The scope of medical devices that would be affected by the new changes includes:
- Sterile medical devices,
- Reusable medical devices (including surgical instruments), and
- Medical devices with measuring functions,
- Class I Software as a Medical Device (SaMD).
To provide a better understanding of the impact of the new Corrigendum it would be important to mention that the European Council is not a legislative EU body and it has no powers to adopt new laws or amend existing ones. According to its status, the European Council could only set the general principles and bring the attention of the authorized bodies to the most important issues. Based on all described above, the Second Corrigendum published by the European Council is a draft that has no legal power and its provisions require to be implemented into the existing regulation by the appropriate legislative body to enter into force–to be adopted by the European Parliament.
At the same time, due to the status of the European Council, the main principles highlighted in the document are more likely to be implemented the nearest time. It is important for medical device manufacturers producing medical devices affected by the proposed changes to keep an eye on the future process concerning actual implementation of the provisions stated in Second Corrigendum.
In case the provisions of the Corrigendum would be implemented “as is”, manufacturers would have additional time to prepare properly submission dossiers for their devices to comply with the new requirements under the Regulations 2017/745 (MDR).
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Sources:
https://data.consilium.europa.eu/doc/document/ST-13081-2019-INIT/en/pdf
https://www.consilium.europa.eu/en/european-council/#
http://ec.europa.eu/DocsRoom/documents/10337/attachments/1/translations/en/renditions/native
