EU MDR Transition, Hurrah!

There is a crackle in the air. EU MDR is now applicable and internationally obliged.

Over the last two years, there has been a steady MDD to MDR transition. Generally, the MDR has been a welcomed advancement for us in Regulatory, Quality x Legal affairs, but there remain procedural delays for many economic operators, including manufacturers, Notified Bodies (NB) as well as corporations and SMEs.

In practice, no doubt there have been some hiccups since the EU MDR was issued in May 2020.

Luckily, the MDR grace period of 2020-2024 reduces any potential limitations moving forward.

For all the assistance presently feasible through the MDR, some but not all manufacturers and distributors remain unprepared, failing to be "fully effective" during the transition period.

Much of this is down to procedural technicalities, and this is to be expected. What appears to stick out so far are manufacturers remaining reluctant to provide full transparency in their submitted datasheets or data fabrication outlines.

Most notably, this happens to be very difficult for manufacturers dependent on multiple external vendors or suppliers.

Yet, companies and manufacturers who started early and who put extra controls to obtain such information ahead of time have appropriately managed the forthwith procedural technicalities.

Article 120.3 vs Article 123.3

A lot of confusion in Europe persists regarding Articles 120.3, which informs manufacturers what regulatory regimes to apply for Medical Devices under the MDR and Article 123.3, which tells manufacturers about what legacy products fall under Article 120.3. In theory, legacy products out of scope will not be subject to MDR housekeeping obligations or such regulatory regimes.

There is something attractive for many manufacturers or corporations in the thought of having to do very little by way of MDR regulation if they have several legacy products that can be exempt under 123.3.

Such a transitional loop-hole has left many scratching their heads. The two provisions appear not to be equated reasonably well.

But this should not undermine a medical device or product’s system quality and feasibility.

Suppose a company that historically has developed legacy medical devices with mature technologies decides to enter a new market segment where new requirements may be exempt, e.g., device/drug combination products.

In that case, the company may have room to reduce some housekeeping obligations, but any QMS deployed should have the objective of satisfying MDR requirements regardless. It’s better to be overprepared than underprepared.

Deadline Recap

Let’s quickly recap. The EU MDR came into force as of 26 May 2017 but has become a European obligation as of 26 May 2020. Since 22 May 2021, there has been recent additions and revisions. Finally, the EU IVDR will take effect on 26 May 2022.

There remains a grace period until May 2024 for manufacturers, Authorized Representatives, distributors, importers, and NB to transition to the MDR IVDR requirements and obligations.

Any valid certificates under the AI MDD, MDD and IVDD, will become void beyond 2024, and no more devices may be placed on the European market under these certificates.

Authorized Representatives

It should also be noted the new advancements regarding Authorized Representatives, also known as EC Reps. Regulation 765/2008 EC of the European Parliament and Council outline obligations for Accreditation and Market Surveillance which is consistent with Regulation (EEC) No 339/93.

This regulation outlines obligations for Authorized Representatives across sectors. The new EU MDR and EU IVDR will replace these regulations. As expected, this has fastened some logistical resistance for economic operators who are in transition.

The EEC Regulation outlines the requirement for an Authorized Representative as:

"means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive".

The definition of an Authorized Representative, according to the EU MDR and IVDR Article 11 is outlined as follows:

"means any natural or legal person established within the EU who has received and accepted a written mandate from a manufacturer, located outside the EU, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation."

The glaring difference, of course, is that all foreign manufacturers must have an Authorized Representative to commercialize Medical Devices or drugs in the EU.

These pressures are going to be difficult for economic operators of all different shapes and sizes.

What makes matters more complicated is that under the EU IVDR, the Authorized Representative must also be required for a foreign manufacturer to commence clinical trials and performance evaluations in the EU jurisdiction.

Strategically, this has been met with some unpopularity and rightly so as European Competent Authorities and NB have been considerably quiet on the nuances involved.

The EU MEDDEV Guidance Directive does fill in the gaps concerning Authorized Representatives. However, it has not been communicated whether the MEEDDEV will still be accommodated under the new EU MDR and IVDR beyond May 2024.

Managing Risk

Substantial but welcomed changes have altered the degree of risk by various means.

However, manufacturers, corporations and businesses, must seriously consider what they must prepare for and what risks they are willing to tolerate during a given transition.

Every operator will tackle EU MDR/IVDR changes differently, but the principle remains the same. Considering unexpected or surprising obstacles will be a part of the process and must be factored into a framework accordingly.