The EU Medical Device Regulation (MDR) has been on the regulatory horizon for a long time.
But, the time for manufacturers to comply with the changes is now, as the three-year transition period which commenced after the regulation’s publication in 2017 is rapidly reaching an end - officially ending on the 26 May 2020.
This deadline will finalise the shift for manufacturers from the previous Medical Device Directive (MDD) to the new EU MDR and represents a significant remodelling of the way in which medical devices are regulated.
As the deadline for EU MDR compliance approaches, Class I manufacturers are under increasing pressure to ensure their compliance with the new regulation, without which they risk losing access to EU markets.
This urgency to conform in time to the post-market provisions of the EU MDR applies not only to high-risk device manufacturers, as it is commonly assumed, but to all Class I manufacturers, too.
Firstly, the EU MDR stipulates that all manufacturers will fall under one of three obligations that they must fulfil in order to retain their products on the EU market.
The deadline will finalise the shift for manufacturers from the previous Medical Device Directive (MDD) to the new EU MDR and represents a significant remodelling of the way in which medical devices are regulated
Manufacturers whose products have been recertified under the MDD prior to the EU MDR deadline can benefit from an extended deadline by up to four years.
But this does not apply to Class I products, which currently do not require a notified body certificate under the MDD, and will therefore require re-registration under the new regulation by the 2020 deadline.
Similarly, Class I manufacturers will also now require a formal Quality Management System (QMS) as per Article 10, paragraph 9 of the EU MDR, which is best served by implementing EN ISO 13485:2016, representing a big step up from the basic procedures required under the MDD.
Class I manufacturers should not underestimate the required additional preparation and resources to demonstrate total EU MDR compliance, particularly for instances where Class I manufacturers are now required to engage with a notified body for the first time
In all other instances, manufacturers must achieve compliance by the 26 May 2020, either by updating all technical information in line with the EU MDR, including clinical evidence, and self-certifying their products (only for Class I products); or updating all technical information in line with the EU MDR and having a notified body review for compliance (includes Class I products that have been up-classified).
The transition from MDD to EU MDR brings with it four new classification rules as well as many changes to pre-existing ones, significantly altering the classification system for medical devices.
Many manufacturers will find that new classifications are applicable to their devices, as per EU MDR Annex VIII, and subsequently that new conformity assessment routes are now required for their product range.
Certain products have received special consideration in the EU MDR and will be subject to medical regulation for the first time: while already Class I devices, re-usable surgical instruments for example, do not presently require a notified body. However, the EU MDR will introduce a new classification for Class I devices known as Class Ir, requiring notified bodies to inspect all cleaning, repackaging and reprocessing aspects.
Furthermore, Class I devices that have been either up-classified to another subsection of Class I or to Class IIa, IIb or even Class III, will also require input from a notified body.
Another important consideration under the EU MDR is the absence of grandfathering of products, which means that even for products that have been on the market for over 20 years, a new CE mark is now required.
As such, Class I manufacturers should not underestimate the required additional preparation and resources to demonstrate total EU MDR compliance, particularly for instances where Class I manufacturers are now required to engage with a notified body for the first time.
Manufacturers who delay their journey towards EU MDR compliance may find that all notified bodies are at full capacity and unable to review their technical documentation
Further complicating the process of compliance preparation within the EU MDR transition period is the considerable depletion of notified bodies across Europe, which has provoked a shortage of regulatory expertise available to manufacturers.
Currently, only two notified bodies have been designated under the EU MDR, a number that is expected to rise to a couple of dozen by the end of this year.
With a clear over demand for regulatory certification services on the horizon, manufacturers should engage with a notified body right away to guarantee they have the capacity to assist, review the technical documentation, and issue a CE certificate within the tight timelines.
At the core of a successful transition is the gathering of clinical evidence.
Post the EU MDR deadline, Class I devices not conforming to the new requirements will be removed from the market, problematically preventing manufacturers from gathering the clinical evidence necessary to complete the technical documentation required under the EU MDR.
Complying now enables manufacturers to use available post-market clinical data or perform a post-market study to submit as clinical evidence within the technical documentation.
The importance of clinical evidence will not diminish after the deadline is met either, as Class I manufacturers will be required to prepare a formal Post Market Surveillance (PMS) report as part of their quality management system, which must continuously and proactively be updated with relevant clinical data, as covered in Article 85.
If the deadline is not met in time, manufacturers will see their right to trade on EU markets revoked, causing cash-flow repercussions, reputational damage as well as loss of market share
Class I manufacturers who stall their EU MDR preparation are at risk.
Firstly, they should stay informed of any classification amendments which may affect the compliance requirements of their products.
Next, manufacturers who delay their journey towards EU MDR compliance may find that all notified bodies are at full capacity and unable to review their technical documentation.
If the deadline is not met in time, manufacturers will see their right to trade on EU markets revoked, causing cash-flow repercussions, reputational damage as well as loss of market share.
In order to achieve CE marking by the 2 May 2020, Class I manufacturers must put EU MDR conformity at the forefront of their priorities in order to allow for enough time to gather the obligatory clinical data and seek assistance from their notified body.
