medicaldeviceslegal

As they say: this is the first day of the rest of your life, and in a way it is. The MDD is dead, long live the MDR!

The (AI)MDD is no more now, but is it?

Three important events happened today that are all relevant to this question: the MDR became applicable, the Swixit that seemed to be entirely avoidable happened anyway by the Swiss throwing their medical devices industry under the bus by walking out on the last minute negotiations to avoid a really hard swixit (my impression of the chain of events) and mysteriously Turkxit did not happen.

Net result: we have a newly applicable MDR, for a smaller Union (minus Switzerland), and the (AI)MDD is still around.

MDR applicable

With the MDR becoming applicable we have now entered the period that many people call the ‘grace period’, which may turn out to be a period of fierce grace to many, during which the MDD and the MDR will actually co-exist much like the Siamese twin monster from Sesame Street, for several years to come. Notified bodies that are not notified anymore for the directives still remain alive for surveillance of these certificates, and these devices may not be subjected to a significant change, as that will lead to termination of the certificate.

During this period, it is crucial for every economic operator dealing with the MDR to understand the legalese part in the back of the MDR: articles 120-123.

Article 120 (3) MDR, as the heading of article 120 suggest, provides for transitional provisions. These apply to devices that have a CE certificate under the AIMDD and the MDD with a validity beyond the date of application of the MDR or a declaration of conformity for a device that would need a notified body assessment under the MDR. All other devices must be fully compliant with the MDR as of today.

Article 120 (3) MDR provides that these devices may ride out the CE certificate or declaration of conformity, provided that the manufacturer already implements certain elements of the MDR: post-market surveillance, market surveillance, vigi­lance, registration of economic operators and of devices in place of the corresponding requirements of the Directives. Article 120 (3) is silent on what the manufacturer needs to do with the all the additional elements of the MDR, such as importer and distributor requirements in articles 13 and 14, the PRRC and the implant card in article 18.

One way to look at it is to say that article 120 (3) intends to create a self-contained bubble of an exemption regime for legacy devices within the universe of the MDR, valid between the date of application and 26 May 2024, but this is not unambiguously stated in the text of the MDR – a kind of space/time anomaly as we know from Star Trek, in which normal rules of MDR physics do not apply.

Another way to look at it is to say that what is not delayed, is not delayed. Article 123 MDR governs the entry into force and date of application of (parts) of the MDR. Notably, article 123 (3) contains a list of derogations from the principle that everything in the MDR is applicable as of 26 May 2021. Some articles referred to in article 123.3 apply before that date (e.g. the articles on national authorities for the MDR and the formation of the MDCG) while others are deferred to later dates, notably article 123 (3) (d) that delays application of everything to do with Eudamed until a later date now that Eudamed is not fully functional before 26 May 2021. Since article 123 (3)is the exemption to everything applying as of 26 May 2021, one must assume that everything not delayed under article 123 (3) is not delayed. The provisions not delayed include articles 13 – 18 MDR, as these are not mentioned in article 123 (3).

If you’d like more detail, check out this podcast in which I discuss these options with Gert Bos.

Given these two seemingly conflicting theories, how can a manufacturer reconcile his obligations for legacy devices?

There are two options.

The first option is to treat article 120 (3) as a self-contained regime within the MDR (the space/time anomaly theory), in which the old provisions of the Directives continue to apply, plus only the MDR elements explicitly mentioned in article 120 (3), imprecise though as these are described there. This option requires that the manufacturer is able to run parallel QMSes for legacy and MDR products for the duration that he still places legacy devices on the Union market. Also, it requires that his supply chain can tell legacy devices and MDR devices apart and treats them differently, because in the space/time anomaly articles 13 (importers) and 14 (distributors) and 25 (traceability of devices) do not apply, but the obligations for registration of devices and economic operators do (see article 120 (3)). You can imagine that this is not for everyone and that many manufacturers that I know choose to just not make this difference.

The second option is to adopt the not delayed MDR obligations ‘early’ and also adopt the MDR elements that are not explicitly mentioned in article 120 (3) but which are also not delayed under article 123 (3) and which are not relevant to MDR conformity assessment only – remember, you don’t have to redo conformity assessment for a legacy device. This allows the manufacturer to transition to a single QMS for all devices, which will not only be practical internally but also for the supply chain. This is also the position adopted by several competent authorities and is supported by recital 98 of the MDR. Recital 98 states that the Directives should  be  repealed  to  ensure  that  only  one  set  of  rules  applies  to  the placing  of  medical  devices  on  the  market  and  the  related  aspects  covered  by  this  Regulation. Of course you could still argue that this one set then makes an exemption for legacy devices, creating the space/time anomaly – but still I think this is not the most logical interpretation.

Which one to choose? I know that this has still not been decided upon in guidance (none of the legacy devices guidance documents addresses this, only registration in Eudamed, see here and here) and that there are different schools of thought on this subject.

The authorities that I spoke with seem to favor option 2 and this is also the option that I think is the more logical of the two.

Swixit

The last couple of days were a wild ride: the Commission and the Swiss were negotiating about an amendment to the Mutual Recognition Agreement (MRA) to avert the worst consequences of Swixit, and the Swiss walked out of these negotiations at the very last day (my impression of events). The more nuanced version of the Commission:

“However, and although we do not expect potential disruptions in the health sector during the COVID-19 pandemic, on 30 March 2021 the EU proposed to Switzerland as a precautionary measure a limited modification of the medical devices chapter of the MRA providing for a transitional validity period for existing devices with Swiss certificates until 26 May 2024 (at the latest) and the same transitional validity for certificates issued in the EU. Despite consistent efforts and EU readiness to conclude such a transitional arrangement, the proposed modification was not agreed ahead of 26 May 2021.

As a result, until a potential agreement on the proposed modification to the MRA is reached, the trade facilitating effects of the MRA for medical devices, including the mutual recognition of conformity assessment results, the absence of the need for an authorised representative and the alignment of technical regulations, cease to apply as from today Wednesday 26 May 2021.”

In other words, remember Brexit? Yep, this is the similar except limited to the devices regulatory framework. For the moment, because absent a comprehensive agreement for Switzerland’s relationship with the EU (the Institutional Framework Agreement, process started in 2014, agreement reached in 2019 and Switzerland refusing to implement it ever since – sounds like Brexit, no?) the EU will push Switzerland out of the internal market one MRA at a time by refusing to renew every MRA that expires because the legislation subject of the MRA changes.

Consequences please! Oh yeah, see this stakeholder notice for that:

• For all new devices, Swiss manufacturers will be treated as any other third country manufacturer intending to place their devices on the EU market. In particular, new Swiss medium and high-risk devices must be certified by conformity assessment bodies established within the EU.
• Existing certificates issued under the MRA by conformity assessment bodies established in Switzerland will no longer be recognised as valid in the EU.
• For existing certificates issued under the MRA by conformity assessment bodies established in the EU, Swiss manufacturers and third country manufacturers whose authorised representative was previously established in Switzerland, must designate an authorised representative established in the EU.
• On 19 May 2021, the Swiss Federal Council adopted an amendment to the Swiss Ordinance on Medical Devices establishing conditions for trade of medical devices covered by EU issued certificates on the Swiss market. This includes the recognition of existing certificates issued under the MRA by conformity assessment bodies established in the EU and transitional timelines for the designation of a representative in Switzerland for EU/EEA manufacturers of medical devices.

Market participants (e.g. affected manufacturers, EU importers and distributors, authorised representatives) as well as EU market surveillance and customs authorities in Member States must now:

• (since existing certificates issued under the MRA by conformity assessment bodies established in Switzerland will no longer be recognised as valid in the EU as of 26 May 2021) ensure that medical devices are certified by an EU conformity assessment body where such certification is required on the basis of the applicable conformity assessment procedure;
• ensure compliance with the requirements for economic operators, in particular the need for an EU authorised representative;
• comply with the requirements on registration and labelling of products.

And this is not all, just what the Commission can tell us today. More consequences still potentially to follow.

No Turkxit

There is basically no public information about the Turkxit having been averted for devices, but I can tell you that the Commission informed the member states that the last steps that were needed to solve the ‘personal data protection issue’ have now formally been taken, and that Turkey is now continuing to be a Union member state for the purposes of the MDR and IVDR.

This will likely have everything to do with Turkey having access to all the personal data in Eudamed, but we will need to see this confirmed in public communication – developing story as they would say in the press.

Turkey had its MDR and IVDR legislation ready to go, and is now a continued valued member of the Union market in which devices can freely circulate once placed on the market lawfully.

Onwards and upwards

Are we discouraged by all this complexity? Of course not.

We have now gone through the looking glass of the MDR, and have found ourselves in the wondrous universe of the MDR that we will need to work with for the coming decades, saying “Curiouser and curiouser!” and sometimes believing as many as six impossible things before breakfast – we may even be agreeing that we’re all mad here.

Personally I’m with the Dodo, who said that “the best way to explain it is to do it.” Onwards and upwards!