Medical technology, or “medtech”, covers a vast spectrum of healthcare products, ranging from everyday products like blood glucose meters, hearing aids, eyeglasses, and wheelchairs to high-tech equipment like molecular diagnostic devices, ultrasound scanners, implantable devices, and replacement joints. Medical technology may include medical devices (MDs), in vitro diagnostics (IVDs), and digital health services, but in this article, medical technology will refer to MDs and IVDs.
The new regulations timeline:
On April 5th, 2017, the European Parliament approved the new Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) (Regulation (EU) 2017/745 Article 117 and Regulation (EU) 2017/746, respectively) set by the European Medicines Agency (EMA). The regulations were published in the Official Journal of the European Union on May 5th, 2017 and entered into force on May 26th, 2017.
MDR will become mandatory on May 26th, 2020 and IVDR on May 26th, 2022. These new MDR and IVDR are expected to gradually replace existing directives by their respective deadlines and considerably alter the framework for medical technology market access for all European Single Market member nations (28 EU member states including the UK and EEA members Iceland, Lichtenstein and Norway) and Switzerland through bilateral agreements.
New MDR / IDVR timeline:
Which medical technologies will be affected and how?
Medical technologies that will be affected under the new regulation are:
1) Medical Devices (MDs): equipments or products intended for diagnosis and treatment of medical conditions; these are either integral (e.g., transdermal patches, prefilled syringes, inhalers) or co-packaged (e.g., a reusable pen that contains a disposable insulin cartridge). The new directive will enforce a mandatory conformity report for all MDs from a notified body.
2) In Vitro Diagnostics (IVDs): non-invasive tests used on biological samples such as body fluids (blood or urine) and tissue to determine one’s health status. Under the new regulation, all IVDs will be re-categorized under a rigorous hazard-based classification system and must include a conformity report from a notified body.
Compliance with this new regulation will be enforced from May 26th, 2020 for MDs and May 26th, 2022 for IVDs.
What prompted the introduction of the new regulation?
The present regulations (set in the late 1990s) do not guarantee the registration of a drug-device combination product. Discrepancies in the categorization of MDs across Europe is also frequent. Due to the lack of specific guidelines, the location of data and amount of published information related to the device element varies across companies. In addition, the chain of scandalous revelations involving fraudulent manufacturing of silicone breast implants by the French company ‘PIP’ (from 2000 to 2016) highlighted flaws in the legal system in place and significantly damaged confidence in the safety of MDs among patients, customers and healthcare professionals.
These new regulations will provide for an updated and robust EU legislative structure to make marketing authorization applicants comply with stricter standards with enhanced traceability, including mandatory inclusion of the outcomes of conformity tests by a notified body. EU regulatory authorities predict that the revised law will help improve the quality of medical devices under a stronger control of certified institutions and enhance the trust of consumers in the MDs industry.
When will the new regulations be enforced and how will it affect existing devices?
Compliance with MDR (EU) 2017/745 for MDs will be enforced only on marketing authorizations filed as of May 26th, 2020. Article 117 will not apply to
- existing devices in the market,
- approved devices about to enter the market and,
- devices filed for approval before May 26th, 2020
However, EMA will enforce the new regulations if there is a significant change in the design or function of the device element of an approved combination product.
IVDR (EU) 2017/746 for IVDs will be imposed on May 26th, 2022 (two years after implementation of the new MDR ) and will be applicable in a similar pattern as the MDs regulation outlined above.
What is the impact of the new regulations on the EU medical devices industry?
The European market for medical technology is estimated at €115 billion (based on manufacturer prices), making up 27% of the world market for such goods, and the second largest after the United States. The EU has approximately 27,000 medical technology companies. Germany is the largest medical device market in Europe (27%), followed by France (15%), the UK (11%) and Italy (10%).
Although more than 30 months have passed since the adoption of the new regulations, there is presently scarce knowledge of how the method to support this new requirement would function or what is the suggested timeline of such an evaluation. With only 5 months left until the regulations are enforced, this presents a critical problem for manufacturers, distributors, consumers, importers and exporters. Concerns are being raised by the EU medical devices industry that this would affect timelines for authorization and delay the marketing of significant medical devices affecting patient treatment, tracking and outcome. A market survey by Medtech Intelligence showed that over half of the companies estimate that compliance to the new regulations will cost more than 5% of their EU revenue. In an open letter to the European Commission on April 15, 2019 from the European MedTech Association, grave concerns were raised over readiness and capacity of the notified bodies:
“The medical device industry in Europe confirms that without immediate action by the European Commission, the new regulatory system will not be ready on time to ensure continued access of patients and healthcare systems to life-saving and life-transforming devices. As of May 2020, thousands of medical devices will become non-compliant and will not be authorized for use by surgeons, doctors, hospitals and patients.”
The inventory of re-certification of existing devices will delay the authorization of new products (the current authorization requires between 3 to 9 months). This is prompting European start-ups, small and medium companies that lack an active infrastructure to meet the MDR / IVDR requirements to head to other countries including China and the United States and other regulatory authorities to get their devices certified and launched.
To assist a smooth transition to the new regulatory framework we provide the following summary of the guidelines below.
Overview of modifications to marketing authorization applications involving medical devices (MDs):
Overview of modifications to marketing authorization applications involving in vitro diagnostics (IVDs):
| Product | Old | New |
| CE Marked device | Less rigorous classification Annex II List A and List B
Clinical and analytical evidence much relaxed. No specific guidelines for device identification and tracing. Consistency and compliance monitoring less frequent. |
Recategorization of devices according to risk:
Class A (low risk- eg. specimen receptacle) Class B (medium- eg. pregnancy / cholesterol self test) Class C (medium-high- eg. HLA typing) Class D (high- eg. HIV blood diagnostic test) Robust clinical evidence for a) safety and b) clinical performance according to the device’s risk category to be collected and submitted by the manufacturer Implementation of unique device identification protocol (UDI) to make it easier to track and withdraw from the market if needed Stringent conformity requirements for IVDs to be scrutinized and approved by the EU notified body before market placements. Mandatory post-market monitoring standards of devices will be significantly increased with reduced reporting time-window. |
| Non-CE Marked device | Less rigorous classification Annex II List A and List B
Clinical and analytical evidence much relaxed. No specific guidelines for device identification and tracing. Self certification allowed. CE mark not mandatory. Consistency and compliance monitoring less frequent. |
Recategorization of devices according to risk:
Class A (low risk- eg. specimen receptacle) Class B (medium- eg. pregnancy / cholesterol self test) Class C (medium-high- eg. HLA typing) Class D (high- eg. HIV blood diagnostic test) Robust clinical evidence for a) safety and b) clinical performance according to the device’s risk category to be collected and submitted by the manufacturer Implementation of unique device identification protocol (UDI) to make it easier to track and withdraw from the market if needed Stringent conformity requirements for IVDs to be scrutinized and approved by the EU notified body before market placements. All products need to be CE marked Mandatory post-market monitoring standards of devices will be significantly increased with reduced reporting time-window. |
Critical choices and prospects for the medical device market:
A significant paradigm shift in the European medtech market is soon to take place under the new regulatory framework. Larger companies with better infrastructure and financial stability may be more able to accommodate the new regulatory requirements, but all companies will need to prioritize and streamline their current manufacturing pipeline and significantly revamp their R&D to pass the stricter conformity requirements. Smaller companies and startups might opt for an economically feasible decision to first receive device authorization from other markets, in particular the US.
Medtech Europe predicts severe delays in re-authorization of existing devices and authorization of new products due to the decline of the number of specialized notified bodies across the EU who are accredited to issue the conformity certificates. However, the new regulations provide the opportunity to open up a new market for regulatory affairs specialists and CROs to fast-track compliance with the new standards to minimize the demand-supply gap.
