Have you thought about the impacts of the Regulation (EU) 2017/745 on your regulatory and normative watch?
The Regulation (EU) 2017/745 on medical devices, together with the ISO 13485: 2016 standard, require manufacturers to implement a monitoring system in order to meet the applicable regulatory requirements.
The identification of applicable regulatory and normative texts is a crucial step that must be considered before the development of a medical device. Continuous monitoring of all identified and applicable texts must then be carried out over the course of the product life cycle to track their evolution.
In this article we provide an outline of the different types of texts that are likely to evolve upon application of the MDR that may help you get ahead on the “regulatory watch” part of your MDR transition action plan.
Regulatory texts
The MDR was slated to enter into force May 26, 2020. However, on April 3, 2020 the Commission published a proposal to extend this date of application by one year, in order to allow industry to focus efforts on the fight against the coronavirus pandemic and to continue to guarantee the health and safety of patients until the new legislation becomes applicable.
Once the MDR enters into force, it will partially repeal Directive 93/42/EEC concerning medical devices and Directive 90/385/EEC on active implantable medical devices.
Why partially?
In short, because of the 2-year delay in the launch date of Eudamed (a possibility that had already been anticipated in the MDR). As long as Eudamed is not fully operational, manufacturers must continue to comply with certain requirements of the Directives, as transposed into national law, concerning the notification of incidents, the registration of devices and economic operators and notifications in the context of clinical investigations.
Also note that on the date of application of the MDR, the Directive 2003/12/EC on the reclassification of breast implants and the Directive 2005/50/EC on the reclassification of hip, knee and shoulder joint replacements will be repealed, as their content has been included directly in the MDR.
However, Regulation (EU) No 207/2012 on electronic instructions for use of medical devices and Regulation (EU) No 722/2012 concerning particular requirements with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin remain in force until they are repealed by future Commission implementing acts.
Reminder: it will still be necessary to monitor the Public Health Codes of the EU Member States. Even though each Member State must directly apply the MDR without transposition, certain national specificities will exist, as is the case for the reprocessing and reuse of single-use devices.
Standards
Monitoring standards can be a real headache. Between international standards, European standards, national standards, harmonized standards, etc. it is sometimes difficult to know which ones to follow.
Once published, harmonised standards will provide presumption of conformity with the General Safety and Performance Requirements (GSPR) of the MDR. However, it is also essential to consider the current state of the art.
This is especially important as the harmonisation of standards with the Regulations is not expected in the very near future. On June 26, 2019, the Commission published a draft document in which it requests a revision of certain standards or the creation of new standards by the European standardisation committees. The Commission then amended this draft request in January 2020 by adding further standards to it. It is thus expected that 150 existing standards will be revised, and 27 new standards will be developed before May 27, 2024. This essentially means that there will likely be no harmonized standards when the MDR enters into force in May 2021. For the moment it is difficult to say how long this “void” will last.
In a document entitled Use of international generally acknowledged state-of-the-art standards in the absence of harmonised standards under the IVDR and MDR, Medtech proposes to apply the following ranking model to different standards or methods used to demonstrate conformity with the GSPR in the absence of MDR harmonised standards:
- The most recent versions of harmonised standards under the current Directives
- Standards identified as candidates for harmonisation under the MDR
- International or European consensus standards
- Other international or European standards
- Standards or procedures developed internally by the manufacturer
Common Specifications
As you may remember, the MDR introduces a new type of document: common specifications.
Common specifications will be adopted by the Commission, after consultation with the Medical Devices Coordination Group (MDCG), for the following specific cases: if there are no harmonised standards, if the applicable harmonised standards are not sufficient, or if there is a need to address public health concerns.
All necessary common specifications will be adopted by May 26, 2021 at the latest; others may be adopted at later dates, as necessary. Their date of application will be either six months after adoption or six months after May 26, 2021, whichever is the later of the two dates.
If a common specification applies to your products, they must comply with it, unless you can justify the use of other solutions that guarantee the same level of safety and performance.
At present, no common specifications have been published. In July 2019, the Commission published a draft common specification for the reprocessing of single-use medical devices; however, the final version is still not available.
A common specification for products without an intended medical purpose as referred to in Annex XVI of the MDR is expected to be published soon.
Guidance documents
Up until now, you’ve likely used the MEDDEVs to help you navigate through product conformity. Much of the content of these guidance documents has been directly integrated into the regulations. However, as the MEDDEVs provide guidance with respect to the directives, they will eventually be replaced by new documents written by the MDCG that provide guidance with respect to the regulations.
The MDCG has been publishing guidance since 2018 regarding critical aspects of the MDR: UDI, Eudamed, person responsible for regulatory compliance, implant card, software, etc.
Click here to access all MDCG endorsed guidance documents.
Delegated acts and implementing acts
Once a legislative act has been adopted, implementing acts and delegated acts allow for its update in order to take into account industry developments or to ensure its proper implementation. The MDR thus provides for the adoption of such acts under situations concerning, for example, the list of products without an intended medical purpose in Annex XVI, common specifications, and medical device classification.
Two implementing acts have already been published by the Commission:
- Commission implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under the MDR and the in vitro diagnostic Regulation. These codes are important in determining the sampling plan for auditing the technical documentation of Class IIa devices.
- Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices.
Amendments and corrigenda
As with the Directives 93/42/EEC and 90/385/EEC, the Regulation (EU) 2017/745 is a text subject to adaptation and modification through the publication of corrigenda and amendments.
Two corrigenda have already been published. The first mainly makes editorial corrections, while the second primarily extends the grace period for Class I devices which change class under the MDR.
Documents developed by stakeholders
Both Competent Authorities and Notified Bodies publish a wide variety of documents that often provide a wealth of information and explain their interpretation of the texts.
Industry-representing associations, such as the SNITEM, also publish clear and concise guidance documents (note: while some are publicly available, others are reserved for members only).
And don’t forget to consult documents published by non-European structures such as the IMDRF, FDA, TGA, etc. They may serve as a source of inspiration on best practices when European regulations leave room for interpretation or ambiguities. As the regulations relating to medical devices are tending towards international harmonisation, it is all the more important to keep an eye on what our neighbours are doing in this sector.
To sum up, your regulatory and standards monitoring will be considerably impacted once the MDR enters into force.
It is imperative, now more than ever, not only to identify all texts applicable to your products and your organisation, but to keep on top of their evolution, to perform Gap and impact analyses, and create and implement actions plans.
The state of the art is constantly evolving, and so your regulatory monitoring system must be solid. nex’inform® is the regulatory and normative watch solution that allows you to save time and focus on the essential, your business.
If you have any questions, don’t hesitate to contact us contact@nexialist.fr
Written by
Chloé Dhordain – Regulatory Affairs Consultant – c.dhordain@nexialist.fr
Camille Pelé – Director, Knowledge Management – Consultant – c.pele@nexialist.fr