It is less than 2 years before MDR and 4 years before IVDR become fully applicable, and medical devices manufacturers requiring notified body certification for CE marking should assess their regulatory position urgently to avoid the situation of not being able to sell their devices in the EU.
Every notified body needs to be authorised by their national competent authority – this process is in progress, but not likely to be completed until sometime in 2019. It is anticipated that fewer notified bodies will be designated to provide certificates under the Regulations (i.e. MDR and IVDR) than is the case under the current law (i.e. the Directives MDD, AIMD and IVDD). It is also possible that some notified bodies will be designated for a narrower range of products than is currently the case.
Notified bodies are already under strain, with some UK ones refusing new customers even for certificates under the Directives. Complaints about delays in certification by notified bodies are currently an all too familiar refrain. In any case, even in the best of worlds, the Regulations represent a new beginning for everyone, and everyone will need time to get their staff and operations up to speed.
For these reasons, in our view, manufacturers ought to allow significantly more time for certification under the Regulations than they had previously, whatever notified bodies might promise. Better to prepare for the worst and be surprised by a better-case scenario than to find that time has run out and your devices cannot be placed on the market, or (even) worse, have to be removed from it.
Equally, manufacturers need to think in advance how long their certificates are valid for under the Directives. We are of the view that manufacturers would be well advised to obtain certificates under the Directives which will provide them with the longest period of validity for both current devices and devices new to the market, rather than wait for certification under the Regulations. Preparation for applications under the Regulations should be undertaken in parallel and not delayed either.
This makes the transition provisions under the Regulations quite pertinent: manufacturers will need to strategise on the timing of their applications for certificates under the Regulations and keep a careful watch on the finite life of their certificates issued under the Directives.
Critical Timings to Consider for devices requiring notified body certification:
A: Legacy Devices: With certificates under the Directives
There are two periods to be aware of:
- Certificates issued under the Directives prior to 25 May 2017 will be valid until the date on the certificate (usually up to 5 years from issue).
- Certificates issued under the Directives from 25 May 2017 will be valid until 27 May 2024 at the latest, but note that according to the transitional provisions in MDR and IVDR, these certificates can only be issued by notified bodies until 25 May 2020 and 25 May 2022, respectively.
If your certificates are in the first category, it would be prudent to reapply under the Directives in order to hold valid certificates with a longer end date (and land in the second category), rather than to wait for your notified body to be certified under the Regulations. We also consider this to be the case under IVDR, even though the timelines are longer, because IVDR imposes significantly more onerous requirements for data to support applications. We anticipate that everyone, including notified bodies, will be on an even steeper learning curve and therefore more significant delays in IVDR certifications are to be expected.
Note however that some notified bodies will likely transfer their teams working under the Directives to work under the Regulations, so will cease to issue certificates under the Directives earlier than the deadlines set out above. Check with your notified body their last date for applications for certification under the Directives.
Manufacturers will of course also have to apply for certificates under the Regulations, but this can be done in parallel and preparatory work for these applications should not be delayed because of the challenges around notified bodies.
B: New Devices: Not yet certified under the Directives
For new devices, there is theoretically a choice to apply for certificates:
(i) under the Directives (if the process can be completed by no later than 24 May 2020 under MDD/ AIMD or 24 May 2022 under IVDD, or earlier if specified by the notified body), with an application under the Regulations at a later date; or
(ii) solely under Regulations once there is a suitably designated notified body.
However, until notified bodies start accepting applications for certification under the Regulations, this choice is not real. Where a manufacturer of a new device is in a position to apply for certificates under the Directives, we would suggest that they do so, and that they prepare for an application under the Regulations in parallel. The requirements for the submission of data for certain devices are lower under the Directives than under the Regulations. Therefore, following our recommended path can allow manufacturers to start selling their devices sooner and obtain the necessary data through post-market studies, which can then be used to support the application under the Regulations.
- Apply for certificates under the Directives to maximise the period of validity of those certificates: don't wait for certification under the Regulations because there are currently too many unknowns. Check the last date that your notified body will accept applications under the Directives.
- Keep an eye on announcements from EU policymakers. Medtech Europe called for the EU policymakers to consider extending timelines for full application of the Regulations. If this happens, some certificates under the Directives might have an extended period of validity.
- Allow significantly more time to apply for a new CE certificate than has previously been required, even if your notified body provides you with optimistic timelines. Our experience is that these timelines are frequently not met.
- Keep a watching brief on your current notified body, but also any other notified bodies who might have applied to certify the types of devices you manufacture: it is possible that your current notified body might not be able to certify all your devices under the Regulations.
- Keep talking to your chosen notified body (and engage with other notified bodies, if you are hedging your bets) to ensure that, as soon as they start to schedule companies for certification under the Regulations, you can be included on that list (cutting down to a single notified body at application stage).
- Be prepared to apply for certification under the Regulations at the earliest opportunity.
- Remember that MDR and IVDR also impose time limits on when devices certified under the Directives might be "placed on the market" and "made available". These limits are illustrated in the diagrams below and are subject to certain conditions being met.
Note: Manufacturers of devices made using non-viable or rendered non-viable (i) tissues or cells of animal origin or their derivatives, or (ii) derivatives of tissues or cells of human origin benefit from an even longer transitional period. If these devices have been legally placed on the market or put into service in accordance with the rules in force in the Member States prior to 26 May 2020, then they may continue to be placed on the market in those Member States concerned, without time limitation.
- Regulation (EU) 2017/745 on medical devices, which comes into full application in May 2020
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices, which comes into full application in May 2022
- Directive 93/42/EEC on medical devices
- Directive 90/385/EEC on active implantable medical devices
- Directive 98/79/EC on in vitro diagnostic medical devices
- Since certificates issued under Annex IV of MDD and Annex 4 of AIMD have no expiry date, MDR sets the expiry date as 27 May 2022. Certificates issued under Annex VI of IVD also have no expiry date, and IVDR sets the expiry date for those certificates as 27 May 2024.
- The device must continue to comply with the relevant Directive, there may be no significant changes in its design or intended purpose and the manufacturer must comply with post-market surveillance, market surveillance, vigilance and registration requirements set out in the relevant Regulation from the date of its application.