The dust of the MDR and IVDR update proposals has settled, and most New Year’s resolutions have shattered into more pieces than the number of documents in an average technical file.
Therefore, we look ahead and list the changes to the European regulatory framework that were suggested for future innovators. As already mentioned, the so-called MDR2.0, ‘EC COM (2025)1023 final’ is a proposal for revision which might be revised and will probably not be implemented or come into force in the foreseeable future. This means that it is highly advised to follow the current version of the MDR if you are in the process of bringing your device to market in the foreseeable future. If you are still in the design and development phase, it is worth keeping an eye out for future changes, as they may impact your company.
This blog will focus on the changes that are explicitly suggested for small and micro enterprises (SMEs) as defined in Commission Recommendation 2003/361/EC:
|
Type |
Headcount |
|
Annual turnover |
|
micro enterprise |
10 |
AND |
<2 million EUR |
|
small enterprise |
50 |
AND |
<10 million EUR |
If your company falls under these definitions, the following changes may apply to you in the future.
PRRC
Current version
Micro and small enterprises [...] shall not be required to have the person responsible for regulatory compliance within their organization, but shall have such a person permanently and continuously at their disposal.
Proposal
Micro and small enterprises [...] shall not be required to have a person responsible for regulatory compliance within their organization, but shall have such a person at their disposal.
Impact
The removal of permanently and continuously at their proposal reflects what is happening in practice already. By hiring somebody outside of the company, it is virtually impossible to be continuously at somebody’s disposal. It will be more realistic to comply with the regulation.
While being on the topic of PRRC, the requirement for formal qualifications is proposed to be removed. If this change makes it into the final version, it will be much easier to implement a PRRC within the company. However, if the PRRC does not have sufficient hands-on regulatory experience, it is a different question that needs to be answered in a case-by-case scenario. You still must comply with clause 6.2 of ISO 13485 regarding HR and setting requirements for various roles in your company.
Notified body fees
Current version
Article50: Notified bodies shall establish lists of their standard fees for the conformity assessment activities that they carry out and shall make those lists publicly available.
Proposal
Article 50.2: Notified bodies shall apply at least a 50 % fee reduction for manufacturers that are micro enterprises [...] and at least a 25 % fee reduction for small enterprises [...].
Notified bodies shall provide manufacturers that are micro or small enterprises [...] the possibility to defer the payment of fees until the relevant conformity assessment activity is finalized.
50.3 The Commission, in consultation with the MDCG, may adopt implementing acts to specify the structure and level of the fees referred to in paragraph 1, considering the need to:
3. protect the interests of micro, small or medium-sized enterprises [...]
50.4 Notified bodies shall ensure that manufacturers, which are micro, small or medium-sized enterprises [...], have access to their conformity assessment activities in a manner that is not less favorable than the manner in which access is provided to other manufacturers.
Impact
While transparency of fees was already mandatory for NBs, the new proposal requires cost reduction for small and micro enterprises, making it more feasible for small startups to pay for conformity assessment for European market access.
The possibility of paying at a later date potentially gives manufacturers more time to raise funds from investors by demonstrating that the assessment is going well. But caution is advised here, as one must still pay within a specific time.
In Article 50, additional principles are proposed to protect SMEs in regulatory processes. How this will look is yet to be seen; however, it is good to see that there is a legal basis to protect SME in the medical device industry.
Medical Device Coordination Group (MDCG)
Current version
103.7 The MDCG may establish standing or temporary sub-groups. Where appropriate, organizations representing the interests of the medical device industry, healthcare professionals, laboratories, patients, and consumers at the Union level shall be invited to such sub-groups as observers.
Proposal
‘103.7. The MDCG shall establish a sub-group with members representing the authorities responsible for notified bodies and may establish other standing or temporary sub-groups. Where appropriate, representatives of the coordination group referred to in Article 49 and organizations representing the interests of the medical device industry, in particular of micro, small and medium-sized enterprises [...], healthcare professionals, laboratories, patients, and consumers at Union level shall be invited to the MDCG and its sub-groups in the capacity of observers.
Impact
While the MDCG was already encouraged to create subgroups with different stakeholders, primarily representatives of large multinationals or established companies, consultants, or authorities take part in these groups. Now the SMEs are specifically mentioned to ensure that they can participate in writing guidance that applies to this group of manufacturers.
Expert panel costs
Current version
106. 13 The Commission may require manufacturers and notified bodies to pay fees for the advice provided by expert panels and expert laboratories. [...]
106.14. The fees established in accordance with the procedure under paragraph 13 of this Article shall be set transparently and based on the costs for the services provided. The fees payable shall be reduced in the case of a clinical evaluation consultation procedure initiated in accordance with Section 5.1, point (c), of Annex IX involving a manufacturer who is a micro, small, or medium-sized enterprise [...].
Proposal
106.9. The Commission shall require manufacturers and notified bodies to pay fees for opinions and advice provided by expert panels. [...]
The fees referred to in the first subparagraph shall be established transparently and based on the costs for the services provided. The fees shall be reduced for manufacturers that are micro, small, or medium-sized enterprises [...], including in the case of a clinical evaluation consultation procedure initiated in accordance with Section 5.1, point (c), of Annex IX involving a manufacturer who is a micro, small, or medium-sized [...].
Impact
At this moment, just the cost for clinical expert panels shall be reduced for SMEs. In the proposal, the clinical and all other expert panel costs shall be reduced for SMEs.
Looking at all proposed changes, including the changes for annex VII and the MDCG guidance on Breakthrough (BtX) devices, it appears that the commission became aware of the challenging landscape for innovation in Europe.
The proposed changes in MDR 2.0 are focused on reducing costs and protecting the interests of SMEs. Combining them with the proposed timelines in the draft regulation on annex VII, the financial business case, and predictable times might help innovation come back to Europe.
Now, what do you do if you want to bring your device to market? This depends on where you are in your product development process. If you are in the final phase and have your submission almost ready, I would say keep your foot on the gas and don't hit the brake.
If your submission is not this year according to your plan, then try to keep multiple scenarios in your planning, depending on changes in timelines and changes in NB fees. Also, be smart about implementing specific procedures early in your QMS. During design and development, you do not really need an SOP for EUDAMED or complaints.
If you're not sure what to do, please reach out to us and we can discuss what's best to do in your situation.
