Last Updated: May 18, 2020 7:44AM
This is the eighth piece in the Lionbridge Disruption Series, a collection of commentary from life sciences experts on how the industry is changing as a result of the COVID-19 crisis.
The EU Medical Device Regulation (MDR, 2017/745) has been underway for years and has hefty implications for medical device manufacturers in Europe as well as for the ecosystem surrounding medical devices including Notified Bodies and Economic Operators involved in the assessment, production, and distribution of medical devices. On April 17, the European Parliament publicly announced a delay of the EU MDR. The delay was the results of a proposal from the European Commission in early April to delay the Date of Application (DoA) by one year.
The delay was passed via urgent procedure through the EU Member States and the MDR amendment (Regulation EU 2020/561) was then published in the Official Journal of the European Union on 23 April. That’s just one month short of the planned DoA, May 26, 2020.
Why is the EU announcing an MDR delay?
The timing of COVID-19 created particularly heavy lifting for the medical device industry. In the midst of the pandemic, the sector was scheduled for major regulatory change.
Now, industry players must balance securing the availability of medical equipment during the COVID-19 crisis, ensuring supply of other important medical devices for patients with critical or chronic conditions, and meeting the new stricter EU MDR requirements that aim to address weaknesses and safety gaps in the current EU system.
All three needs carry their own ethical weight and bearing on the well-being and safety of patients. This is exactly what makes the current situation an unprecedented burden for industry and regulators. In order to help industry and authorities prioritise COVID-19, the European Commission therefore made the tough but necessary call to adopt the proposal from the European Commission to postpone MDR.
What other issues have delayed MDR?
Although the delay impacts MDR only, MedTech Europe has encouraged the European Commission to postpone the implementation of IVDR. Currently, IVDR is set to take effect on May 26 2022. The European Commission had previously been encouraged to delay the regulatory enforcement date of MDR due to a lack of Notified Bodies accredited under MDR and missing industry guidance. Manufacturers trying to prepare for MDR compliance have been struggling with the cloud of uncertainty. According to NANDO – the European Commission’s database over Notified Bodies – only 13 Notified Bodies have so far been designated under MDR out of the 44 applications received. The delay of the EU MDR falls on top of a two year delay announced last year of Eudamed – the database holding information on medical devices and originally planned for launch in parallel with the MDR in 2020.
The postponement of MDR was not taken lightly by the European regulators. It is a testimony to the extraordinary circumstances surrounding COVID-19. The severity of the crisis and the delay is clear just by reading the rather unusual language used in the amended law text which is full of emphatic phrases such as ”unprecedented challenge,” ”extraordinary circumstances,” ”immense burden” and ”unprecedented magnitude.”
What clinical clarity is available during the delay?
The MDR postponement comes simultaneously with four new important clinical guidance documents which were released in April by the Medical Device Coordination Group (MDCG).
- MDCG 2020-5: Guidance on Clinical Evaluation – Equivalence
- MDCG 2020-6: Guidance on Sufficient Clinical Evidence for Legacy Devices
- MDCG 2020-7: Guidance on PMF Plan Template
- MDCG 2020-8: Guidance on PMCF Evaluation Report Template
The four publications offer a long awaited industry guidance on clinical evaluation requirements under the MDR.
Article 61 of MDR introduces the concept of ”sufficient clinical evidence” as demonstration of the performance and safety of medical devices prior to CE marking. However, that term is not specifically defined in the MDR and the regulatory enforcement of sufficient clinical evidence has been the subject of more questions than answers since the MDR was released back in 2017. The new guidance from MDCG clarifies the definition: ”sufficient clinical evidence is understood as the present result of the qualified assessment which has reached the conclusion that the device is safe and achieves the intended benefits.” Despite being a rather general statement, the term ”present results” clearly indicates that clinical evidence is an ongoing commitment. Manufacturers are required to implement a continuous clinical evaluation process throughout the device lifecycle. All manufacturers seeking CE marking in the EU must document a clinical evaluation plan as well as a clinical evaluation report containing the clinical evidence and results generated for each device. Also, they are obligated to do Post Market Clinical Follow-up (PMCF) to confirm the safety and performance throughout the expected lifetime of the device.
What are the clinical routes for medical devices in EU?
Put in simple language, the technical evidence required to demonstrate clinical and safety performance of medical devices may follow two overall regulatory routes for CE marking. In the ”substantial equivalence” pathway, the device is claimed and demonstrated to be equivalent to an already marketed device. For the clinical investigational avenue, the device is tested in a controlled clinical trial setting.
The route of substantial equivalence is widely used both in EU and US to obtain market clearance for devices that do not require full pre-market regulatory review. However, under MDR the substantial equivalence approach has become more difficult. This is especially true if the equivalent marketed device is manufactured by a competitor. In that case, this route requires an ongoing, contractual access to the full technical documentation of the competitor’s device. How many competitors will be willing to disclose their complete technical file to a competitor, just to witness their own share of market shrink?
Where can manufacturers find help?
Lack of access to competitors’ technical data may force manufacturers to generate their own clinical data through clinical studies. Well-controlled clinical studies are expensive and time consuming and require infrastructure and expertise.
For most class III and implantable devices, clinical studies will become a default requirement under MDR. Just as with medicinal drugs, clinical investigations for medical devices are subject to Good Clinical Practices (GCP) and shall follow ISO 14155 standards.
When MDR takes effect in 2021, manufacturers may face the challenge of conducting clinical device studies if the equivalence route is no longer viable for obtaining CE marking. Besides infrastructure and GCP expertise, multinational clinical device investigations require more content and translations to obtain the necessary regulatory trial approvals when patients are enrolled across EU Member States.
Any communication directed to trial participants will need local language and ethics approval including for example Informed Consent Forms, labeling, user instructions or data captured directly from patients such as Patient-Reported-Outcomes. Having a language services provider with dual experience within GCP and medical devices will be key to a smooth study execution and eliminate inconsistencies or compliance gaps caused by language.
Lionbridge has translated essential clinical documentation for GCP studies for over two decades.We partner with trial sponsors of both medicinal drugs and medical devices to help ensure reliable clinical data in all markets. We manage the full life cycle of translations. Our work includes:
- clinical trial approvals
- linguistic validation of Patient-Reported Outcomes
- plain language Summaries of Safety and Clinical Performance (SSCP).