MDCG 2022-14: Transition to the MDR and IVDR – Notified Body Capacity and Availability of Medical Devices and IVDs
On 14 June 2022, the European Health Ministers met and echoed concerns surrounding the preparedness of medical device and IVD manufacturers for Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) conformity. If left unaddressed, the lack of preparedness may lead to the disruption of the supply of devices needed for health systems and patients, and could also jeopardize the access of innovative medical devices to the European market.
In an effort to mitigate these concerns, the Medical Device Coordination Group (MDCG) issued a new guidance document on 26 August 2022 to ensure sufficient Notified Body capacity and preparedness of manufacturers in order for medical devices and IVDs to be certified under the MDR and the IVDR, respectively, within their defined transition periods.
This document consists of 19 recommendations, including 11 actions relating to increasing Notified Body capacity, 2 covering access to Notified Bodies, 3 on the increased preparedness of manufacturers and 3 other actions.
Highlighted below are some of the significant points covered in the MDCG document broken down into the four areas referenced above.
The following content in italics and red text represents NAMSA’s commentary on the proposals.
Increasing Notified Body Capacity
1. Use of hybrid audits by Notified Bodies (e.g. full or partial remote audits) to allow more efficient use of Notified Body resources.
The option of using hybrid audits will certainly help to increase Notified Body capacity and allow more efficient use of resource since the time presently allocated for travel will be available. However, details are missing regarding specific criteria to allow hybrid audits to occur and whether all types of audit will be acceptable (e.g. will hybrid audits be acceptable for initial MDR/IVDR audits?
2. Notified Bodies to develop processes to allow the use of information obtained from audits conducted under the Medical Device Directive (MDD)/In Vitro Diagnostic Directive (IVDD) by either themselves or other Notified Bodies to reduce duplication. This information can be used in the conformity assessment process for the MDR/IVDR as long as it can be shown that the requirements of the MDR/IVDR have been met.
In most cases, it seems that only areas that remain similar between the regulations and directives will be able to use this process. Clinical evidence is one area where the requirements for MDR/IVDR have been significantly increased; therefore, it is unclear how clinical evidence, which was suitable for MDD/IVDD requirements, might be sufficient to be used for the review against the new EU Regulations. Whilst this clause is well-intentioned, more clarification about its practical implications is required.
3. Appropriate surveillance of ’legacy devices’, Notified Bodies should make full use of the “flexibility” in MDCG 2022-4: Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD.
This is applicable in areas such as combined Regulation/Directive audits for ‘legacy devices’ with an application for MDR/IVDR certification being reviewed by the Notified Body, focused on assessment of compliance with MDR/IVDR requirements instead of surveillance of compliance with Directives’ requirements or with abandoned sampling plans for technical documentation assessments under Directive 93/42/EEC.
There is also a commitment from the MDGC to review and update MDCG 2022-4 and to produce suitable guidance for IVDs.
The comments above are in some cases at variance with MDCG 2022-4. Section 4.4 of that MDCG document, states “the audit activities to be performed by Notified Bodies should be a continuation of the previous surveillance activities with a focus on the new provisions”, which does not appear to give much flexibility.
Section 5.2 also states “In case of class IIa and IIb devices, Notified Bodies are requested to continue applying the sampling plan established under the MDD for the assessment of the technical documentation on a representative basis.” This is a contradiction as the above comment references the abandoning of sampling plans.
There is also no indication on whether unannounced audits should still be conducted for ‘legacy devices’ under the MDD/IVDD, which could help reduce the pressure on Notified Body resources.
This clause requires more clarification, particularly in relation to the contradiction of requirements outlined within MDCG 2022-4.
4. The MDCG will review its guidance documents to eliminate any unnecessary administrative workload placed on Notified Bodies.
The opportunity to streamline MDCG guidance is welcomed, but more importantly to remove areas of uncertainty and/or ambiguity of interpretation by both manufacturers and Notified Bodies, such as the case of applicability of “Well Established Technologies” to devices not listed in MDR Article 61(6b).
5. Concerning the European Databank on Medical Devices (EUDAMED), Notified Bodies should be enabled to upload relevant information machine-to-machine as a top priority.
This will require resources from the EU Commission to introduce this process onto EUDAMED.
6. Notified Bodies should rationalize and streamline their internal administrative procedures.
During the MDR designation process, Notified Bodies will have ensured that their internal procedures and processes are already optimized for efficiency as the MDR/IVDR significantly places more requirements on Notified Bodies which have to be documented in their Quality Management System (QMS). Therefore, the scope for rationalizing processes in this area is expected to be limited.
7. Changes to the periodic re-designation of Notified Bodies highlighted by the preparation of Commission Delegated Acts to modify the frequency of complete re-assessments of Notified Bodies. Presently, re-designation must be conducted 3 years after notification. The proposal is to defer this to 5 years after notification.
This recommendation is to be welcomed as it should reduce the pressure on resources in both Notified Bodies and Competent Authorities in the relatively short term.
8. The MDCG requests all parties involved in the designation of new Notified Bodies to “speed up their processes” to ensure the timely designation of new Notified Bodies.
Although a well-intentioned statement, it would be surprising to believe that the parties involved in this process have not already been working hard to designate as fast as possible (and it is clearly in the Notified Bodies best interest to get designated as soon as possible).
9. The MDCG will review the process for adding codes to Notified Body designations via expedited processes (e.g. the depth of the review to be reduced). It should also be noted that the lifting of conditions or limitations of designations, as well as changes within codes, should not be considered as an extension of the scope of designation.
This potential streamlining should be welcomed.
10. The MDCG will look at revising section III.6. of MDCG 2019-6 revision 3 regarding the meaning of ‘personnel employed by the Notified Body’. This presently requires strict requirements on the employment contracts of those employees in Notified Bodies conducting key functions (e.g. Certification decision makers).
This is causing particular problems for those Notified Bodies who have employees based around the world. It also restricts the pool of suitable new employees who can undertake these roles and help reduce backlogs if a direct employment contract is required. There are many suitable employees outside of Europe who can adequately undertake these roles.
However, the comment above does not indicate that any change to these requirements is imminent with just a review of the requirement presently being envisaged.
11. The MDCG reminds all stakeholders that their guidance documents are primarily to ensure a harmonized approach to the requirements of the regulations. However, flexibility should be used to ensure that the legal requirements are met (e.g. the documents are considered guidance, which are not mandatory, and should be used flexibly).
Also, if new guidance is issued, then this should not be immediately implemented, e.g. “new guidance should not be applied to ongoing processes or applications already launched by a Notified Body for designation and/or a manufacturer for conformity assessment unless the application of such guidance yields increased efficiency of the process”.
A more general point is that some guidance documents can cause more problems. A good example is the situation with “Well Established Technologies” and the different interpretations by different Notified Bodies of MDCG 2020-6. This clause references that more flexibility should be used, which in practice will lead to less harmonization and cause the same issues noted with the MDD/IVDD with different requirements depending on the Notified Body or Competent Authority who has jurisdiction over the certification. This could lead to a deviation from the need for a “level playing field” for all medical device and IVD manufacturers. It will also make it much more difficult for manufacturers to plan for MDR/IVDR approval if they are unsure what interpretation will be used by their Notified Body.
Clarification on expectations would be preferable, rather than flexibility in interpretation by the Notified Body.
Access to Notified Bodies
12. The MDCG reminds Notified Bodies of their obligation to make their standard fees publicly available, particularly considering the interests of SMEs concerning fees. The MDCG also encourages the use of Notified Bodies with published fees for easy comparison.
Whilst understanding the need for transparency in relation to fees, this requirement does not take financial reality into account. A Notified Body based in, for example, the Nordic region might have different labour costs compared to a Notified Body based in Eastern Europe; therefore, their fees will obviously be higher. There is also no correlation between the resources of a Notified Body and the fees they charge; thus, a manufacturer utilizing a lower-cost Notified Body does not necessarily mean that they will obtain quick access to the Notified Body. Understanding the existing capacity constraints with Notified Bodies, the availability of standard fees is the least concern for manufacturers.
13. MDCG calls on Notified Bodies to develop schemes to allocate capacity for SME manufacturers and first-time applicants, and ensure SMEs and first-time applicants access to Notified Bodies for conformity assessment.
Although both these appeals are understandable, they do not address how Notified Bodies with limited resources will allow them to allocate new resources to new and/or small manufacturers when they have contractual agreements with their existing clients regarding CE certification. The overall issue is a lack of resources in Notified Bodies and, more critically, the lack of suitable candidates to fulfil roles at all levels of the Notified Body.
Increase Preparedness of Manufacturers
14. The MDCG reminds manufacturers of its notice MDCG 2022-11: MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements.. The MDCG also calls on manufacturers to ensure timely compliance with IVDR requirements as soon as possible.
Although manufacturers should make all efforts to ensure their readiness and compliance with the MDR/IVDR requirements, to place the main burden on manufacturers is not reasonable given the substantial delays with Notified Body designation and in issuance of guidance (e.g. we continue to await the MDCG addressing PSURs). This area is primarily under the control of the MDCG and regulatory authorities who should ensure that requirements are fully disseminated and understood, and that there is sufficient capacity to process MDR/IVDR applications of legacy devices in a timely fashion. This is still an area where improvement from the regulatory authorities is required.
15. The MDCG encourages Notified Bodies and manufacturers to organize structured dialogues before and during the conformity assessment process, and emphasize that these dialogues will not be considered consultancy.
This proposal requires further clarification. During MDR designation audits, the requirement to not offer consultancy was reviewed to great depth and even a hint of consultancy was considered to be not acceptable. Again, if harmonization is to be preserved, then specific guidance on the limits of consultancy needs to be issued; otherwise, Notified Bodies might consider this an action that is too risky and could jeopardise their designation if they overstep the consultancy line.
16. Increased communication by all relevant parties (EU Commission, Competent Authorities, other Regulatory Bodies and Notified Bodies) with manufacturers via various training methods (webinars, workshops, targeted feedback and formal training sessions). Notified Bodies are also encouraged to work on common guidelines to assist manufacturers in the application phase. Industry associations are also requested to promote and ensure awareness of the legal requirements.
Any action that works towards the “level playing field” of consistent Notified Body approach and interpretation should be welcomed.
For safe and effective ‘legacy devices’, including orphan devices, the complexity of conformity assessments should be reduced, and more pragmatism ensured concerning the demonstration of compliance with the applicable requirements. For this purpose, the MDCG commits to undertake the following additional actions with the highest priority:
16. Provision of additional guidance to Notified Bodies and manufacturers to assist with applying Article 61 MDR (clinical evaluation) and possibly Article 56 IVDR (performance evaluation and clinical evidence), with the possibility for Notified Bodies to issue certificates under conditions of, or combined with, the requirement to carry out PMCF/PMPF studies.
As previously mentioned, any guidance which is issued should be unambiguous and not open to interpretation; otherwise, this is likely to cause more delay instead of speeding up the process.
17. The MDCG acknowledges the specific situation of ‘orphan devices’ and will pursue work to provide a definition for ‘orphan devices’, and suggest specific guidance or other means of assistance for those products to meet the legal requirements.
Bearing in mind that we are less than 20 months away from the end of the Article 120 transition period, this definition and guidance is a priority.
18. The MDCG urges medicines authorities to accept and efficiently process consultations by Notified Bodies regarding medical devices incorporating an ancillary medicinal substance and companion diagnostics.
Medicines authorities should ensure that an expedited review is carried out in case of devices already certified following a medicines authority’s consultation under MDD/Active Implantable Medical Devices Directive (AIMDD).
Medicines authorities are invited to support Notified Bodies in identifying the availability of medicines authorities for the relevant devices.
This does not resolve the main issue of a lack of relevant resources in the Competent Authorities to carry out these reviews. With the removal of the Medicines and Healthcare products Regulatory Agency UK (MHRA) from the process, the overall capacity in the system has been significantly reduced with no obvious increase in capacity within other Competent Authorities.
Finally, derogations from applicable conformity assessment procedures may be granted by Competent Authorities only if the use of the device concerned is in the interest of public health, patient safety or patient. The MDCG will explore the application of such measures and, where relevant, work towards a coordinated, transparent and coherent approach.
It is unclear whether this is indicating that the use of derogations will be more widely used or whether the intent is to try and restrict the use and stop some Competent Authorities given broad approvals in their jurisdictions to overcome any shortfall in medical devices due to the issues raised above. More clarification is required on these comments.
Firstly, the publishing of this MDCG document acknowledges that there are significant issues related to the implementation of the MDR/IVDR and attempts to mitigate some of the issues. Several pragmatic recommendations are included, which will hopefully help increase the capacity of Notified Bodies and ensure that manufacturers are as prepared as possible to understand the new requirements.
However, the fundamental issue of an overall lack of resources and experience in medical device and IVD regulation, particularly within Notified Bodies, will remain exacerbated by the increased requirements in the new regulations. It remains to be seen whether these proposals are sufficient or if further actions will be required in the future, and whether existing guidance will also require modification to reduce the current level of interpretation and confusion.
How Can NAMSA Help?
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. Our internal teams of medical device and IVD development experts communicate with EU entities nearly every day and are the most experienced in industry at accelerating regulatory submissions and approvals for manufacturers. In fact, many of our Associates have previously held positions within these organizations, which provides Clients the benefit of a clearer understanding on how to proactively plan for international requirements and expectations.
To learn about NAMSA’s full suite of Regulatory and Quality services and solutions, including MDR and IVDR compliance planning, please visit: https://namsa.com/services/regulatory-and-quality-consulting/.
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Kevin Butcher is an experienced Senior Manager with extensive knowledge of medical device regulatory requirements, including Product Technical Files and QMS 3rd Party auditing. Mr. Butcher possesses 18 years of Notified Body experience, latterly as Certification Manager for SGS United Kingdom. Kevin joined the medical device consulting team at NAMSA in January 2021 and currently serves as a Principal Regulatory Consultant.
Alex Laan has been in the IVD and Medical Device industry for a total of 20 years with 12 years spent working for a respectable EU Notified Body. Alex has held the position of Principal Certification Manager at DEKRA Certification BV, a Notified Body for IVDs and Medical Devices located in Arnhem, The Netherlands. Mr. Laan also worked for KEMA Quality, beginning in 2006, where he was qualified for Lead Assessor for Medical Devices and IVD devices, Device Specialist reviewer in IVDs and Medical Devices, including drug-device combinations. In these roles, Alex managed projects with large multinationals (e.g., Boston Scientific), as well as small start-up companies. Alex has been an active member of IVD working group within EU Notified Bodies and TEAM-NB and acting as direct contact for EU competent authorities and EMA on implementation of the EU IVDR (2017/746) and EU MDR (2017/745).