The Basis for Regulation of Medical Devices in Portugal
To understand this component, it is important to define what is Medical Technologies, Medical Devices and Digital Health.
Medical Technologies (MedTech) “are products, services or solutions used to save and improve people’s lives” 0.
There are three main categories of MedTech 0:
• Medical Devices;
• In Vitro Diagnostics;
• Digital Health Solutions.
Medical Devices “are products, services or solutions that prevent, diagnose, monitor, treat and care for human beings. A medical device can be an instrument, apparatus, appliance, software, implant, reagent, material or other articles. From syringes and wheelchairs to cardiac pacemakers and medical imaging technologies (such as MRI, CT and X-ray machines), medical devices can play a range of roles in maintaining and restoring health” 0.
“Medical devices are used, either alone or in combination, for individuals for one or more medical purposes:
- Diagnosis, prevention, monitoring, treatment, or alleviation of disease;
- Diagnosis, monitoring, treatment, alleviation, or compensation for an injury or handicap;
- Investigation, replacement, or modification of the anatomy or of a physiological process” 0.
In Vitro Diagnostics (IVDs) “are non-invasive tests used on biological samples (for example blood, urine or tissues) to determine the status of one’s health. IVDs never come into direct contact with a person as they provide information based on a sample. Their value resides in the quality of information they provide. IVDs do not treat patients but their role is to provide information that enables patients and healthcare professionals to make healthcare decisions.
Examples of in-vitro diagnostic tests:
• Hepatitis or HIV test;
• Clinical chemistry;
• Coagulation test systems;
• Urine test strips;
• Pregnancy tests;
• Reagents and reagent products for the detection of infections;
• Blood sugar monitoring systems for diabetics;
• Receptacles manufactured specifically for medical specimens” 0.
Digital Health Solutions are “information and data generated by medical technologies play a vital role in improving health outcomes and make health systems more efficient”.
Digital health and care refer to tools and services that use information and communication technologies (ICTs) to improve prevention, diagnosis, treatment, monitoring and management of health and lifestyle. Digital health and care have the potential to innovate and improve access to care, quality of care, and to increase the overall efficiency of the health sector.
Digital tools will play a central role in many of the most promising areas of healthcare innovation. As we advance towards a more personalised, predictive, precision healthcare, data will be key. In the future, healthcare can be more integrated, value-based and with a stronger focus on patient outcomes 0.
The regulations for Medical Devices (MD) and In-Vitro Diagnostics (IVD) are currently in a state of transition across the EU. For many years both have been regulated under key EU directives.
In May 2017 the European Union (EU) parliament approved the EU Medical Device Regulations (MDR) which came into force on 26th May 2017.The framework defined by this new regulation will define the future development of Medtech.
Manufactures while working today under the old directive’s framework must establish a gap analysis plan for the new regulation in order to be compliant within 2021 and 2022.
Expiring EU Medical Devices and In-Vitro Diagnostic Medical Devices Directives
There are currently three main European Union directives associated with medical devices and in-vitro diagnostic medical devices:
• Medical Devices Directive 93/42/EEC 0;
• In-Vitro Diagnostic Medical Devices Directive 98/79/EC 0;
• Active Implantable Medical Devices Directive 90/385/EEC 0.
Manufacturers and importers must meet the essential requirements (e.g. safety, quality and performance) in the relevant directives before a CE mark can be applied and a product can be legally marketed or sold in the European Economic Area (European Union member states, plus Iceland, Liechtenstein and Norway). In addition, the European Economic Area, the CE mark is also applicable in Switzerland and Turkey 0.
Further information and guidance on the EU directives for medical devices and in-vitro diagnostics can be found on this link.
On 25 May 2017, two additional regulations on medical devices and in-vitro diagnostic entered into force in the European Union and will progressively replace the existing directives. These new regulations will be fully applicable in May 2021 for medical devices and May 2022 for in-vitro diagnostic medical devices and will have binding legal force throughout every EU member state, on par with national laws 0, 0.
Further information and considerations on the transition to the new EU regulations can be found below.
Transition to the New EU Regulations for Medical Devices and in-vitro diagnostics
Manufacturers will have to comply with medical devices and in-vitro diagnostics regulations by May 2021 and May 2022, respectively. After these dates, no new CE marking certificates will be issued based on the old directives for medical devices and in-vitro diagnostics, and existing certificates based on the old directives will have only limited validity 0, 0.
Impact and considerations for innovators
It is critical for innovators to start the transition to the new EU regulations for medical devices and in-vitro diagnostics as soon as possible to allow for sufficient time to (re)establish conformity with the new regulations as well as to account for (unexpected) delays in the certification process due to 0:
- a high number of devices on the market;
- an anticipated bottleneck in reviews by Notified Bodies;
- the ongoing need to interpret certain provisions of the regulations.
There is a shortage of Notified Bodies: in April 2020, out of 58 previously Notified Bodies only 13 have been re-certified for the MDR. It is recommended to approach Notified Bodies as soon as possible to check whether they intend to apply for designation under the new regulations and by when they think they will be ready 0.
Further guidance on the preparations required for the new regulations can be found on this link.
Innovators must anticipate and prepare for the potential challenges and bottlenecks in the regulatory process during the transition period from old EU directives to new regulations: with a high number of products that need to undergo re-certification (besides new products being developed), a limited number of re-certified Notified Bodies, stricter and more demanding certification requirements as well as remaining uncertainties on interpreting regulatory provisions, significant delays are expected in the regulatory process.
It will be essential for innovators to contact Notified Bodies early on to better understand regulatory timelines and to be able to start the process as soon as possible.
New EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR)
The rationale for the new EU Regulations
The current EU directives on medical devices and in-vitro diagnostics were harmonised in the 1990s.
Challenges associated with diverging interpretation of the existing rules as well as certain severe incidents (e.g. the famous scandal of the Poly Implant Prothèse company that utilised cheaper industry-grade silicone to produce breast implants with severe or lethal consequences to patients) highlighted weaknesses of the current legislation and damaged the confidence of the population in the safety of medical devices and in-vitro diagnostics 0, 0.
To resolve these issues and to consolidate the role of the EU as a global leader in the sector, the new Medical Devices Regulation (MDR, 2017/745) and In-Vitro Diagnostic Medical Device Regulation (IVDR, 2017/746) will replace the three existing directives (93/42/EEC, 98/79/EC and 90/385/EEC) 0, 0.
The new regulations are intended to ensure 0:
- a consistently high level of health and safety protection for EU residents using these types of products;
- the free and fair trade of products throughout the EU;
- that EU legislation is adapted to the significant technological and scientific progress occurring in this sector over the last 20 years.
Main changes with the new EU regulations
The core concepts of EU regulation of medical devices and in-vitro diagnostics regulation have remained unchanged in the new EU regulations in comparison to the old EU directives 0, 0:
- no central regulatory authority for medical devices and in-vitro diagnostics (unlike marketing authorisation by the European Medicine Agency for medicines or by the US Food and Drug Administration for medicines and medical devices);
- declaration of conformity (with the CE mark) for medical devices and in-vitro diagnostics is required after following a conformity assessment procedure, which depends on the class of the product and may require the involvement of Notified Bodies for certification;
- harmonised standards remain a way of ensuring compliance;
- non-EU-manufacturers can import medical devices and in-vitro diagnostics if they have an EU representative
Explain the changes introduced by the New Regulation
- Re-certification needed under the new regulations: all currently approved medical devices and in-vitro diagnostics must be re-certified to the new requirements.
- Common specifications: the EU Commission or defined expert groups, such as the new Medical Device Coordination Group (MDCG) can publish common specifications, which will apply to both manufacturers and Notified Bodies, and will apply in parallel to any harmonised standards that may already exist.
- Stricter requirements for Notified Bodies: the new regulations have established uniform and more stringent requirements for the designation and monitoring of Notified Bodies by national competent authorities of the EU. The consequences of these stricter requirements may be that there will be fewer Notified Bodies designated for certification of medical devices and in-vitro diagnostics in the future.
- Unique product number system and European data bank: a unique device identification (UDI) system is intended to facilitate the traceability of products to manufacturers and authorities, thereby enabling the rapid and efficient recall of medical devices or in-vitro diagnostics posing a security risk. Furthermore, the existing European Data Bank for Medical Devices (EUDAMED) will be increased in scope and become partially public, improving access to information about approved in-vitro diagnostics (e.g. actors, UDI, notified bodies, certificates, vigilance, clinical investigations, performance studies and market surveillance).
- Stricter post-marketing monitoring: the new regulations extend the Notified Bodies’ role regarding post-market monitoring with unannounced audits, random checks and product audits strengthening the EU’s implementation processes and helping to minimise the risk posed with medical devices.
- Designation of a “Regulatory Compliance Officer”: manufacturers must designate in their organisation at least one person ultimately responsible for complying with the requirements of the new regulation and each organisation must prove that this individual is appropriately qualified.
Changes with the new EU Medical Device Regulation (MDR)
The most important changes specific to medical devices are listed below 0.
- Extension of the scope: definitions of medical devices and active implantable medical devices are greatly expanded and now include, for example, products without a medical purpose, such as colour contact lenses as well as implants and fabrics for aesthetic purposes. Disease prediction products (incl. software) may also fall under the scope of the regulation.
- Reclassification of products by risk, duration of contact and invasiveness: manufacturers must review the new classification rules and update the technical documentation of existing products accordingly. It should be noted that more stringent clinical requirements apply to Class III medical devices and implantable devices.
- Systematic clinical evaluation of class IIa and IIb medical devices: manufacturers will need to ensure compliance with new, stricter requirements for clinical evaluations, taking into account the updated regulation for equivalence of products as well as circumstances under which a clinical investigation can be absent.
- Stricter clinical evidence for Class III medical devices and implantable devices: manufacturers who do not have sufficient clinical evidence to prove the required safety and performance of a particular product must conduct a clinical investigation and are required to collect and retain clinical data to continuously assess potential security risks (materiovigilance).
- Scrutiny procedure: the new regulations introduced an additional control procedure for Notified Bodies’ conformity assessment for high-risk medical devices (certain class IIb and implantable class III products) through an independent panel of experts. This is likely to extend the duration of the conformity assessment procedure even further.
- Expansion of the definition of in-vitro diagnostics: definitions of in-vitro diagnostics will also include high-risk products manufactured and used within a single healthcare facility, in-vitro diagnostics as well as genetic and other tests that provide information about the predisposition of patients to a particular disease or the effect of treatment.
- New Classification System: a new, risk-based classification system based on the principles of the Global Harmonisation Task Force (GHTF) was introduced; the system includes risk classes ranging from A to D, where A represents low-risk products and D represents the highest-risk products for patients and the public. Manufacturers must review the new classification rules and update the technical documentation of existing products accordingly.
- Stricter specifications regarding technical documentation and clinical evaluation: technical documentation will be expanded and manufacturers must conduct a clinical investigation to demonstrate that product safety and performance are sufficient for the particular risk class of their product (e.g. for class III medical devices). In addition, manufacturers are required to collect and retain clinical data to continuously assess potential security risks (materiovigilance).
- Greater involvement of Notified Bodies and of other external stakeholders: the risk-based classification system introduced with the new regulation is expected to require the involvement of a Notified Body for the approval of all in-vitro diagnostics, with the exception of class A products. It is therefore assumed that more than 70% of all in-vitro diagnostics will have to be examined by a Notified Body (currently less than 15% of in-vitro diagnostics are examined by a Notified Body). Furthermore, when assessing the conformity of high-risk class D products, the competent authorities as well as reference laboratories may be involved, which is likely to extend the duration of conformity assessment procedures.
What impact will MDR/IVDR have for SMEs?
The new MDR/IVDR regulations present the entire Medtech industry with a major operational and strategic challenge, the effects of which will severely impact the business performance of many companies, especially SMEs.
What impact will MDR/IVDR have for SMEs? (in the perspective of the SME)
What impact will MDR/IVDR have for SMEs? (in the perspective of the SME)
The new EU regulations for medical devices and in-vitro diagnostics introduce a series of significant changes and additional requirements that will increase the efforts and investments required from innovators aiming to gain market approval for their products in the European Union.
Contrary to medical devices, manufacturers of in-vitro diagnostics could still consider seeking certification under the older EU directives before May 2022, potentially benefiting from better availability of Notified Bodies that are not yet certified under the new EU regulations. However, innovators would need to evaluate carefully whether this would result in lower overall investments, as re-certification according to the new regulations would need to be started again as soon as May 2024.
For innovators preparing for the certification process in the coming years, it will be critical to analyse the new regulations in detail as well as to closely follow ongoing discussions about practical interpretation and implementation of the law to be ready when the time comes.
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Question 1 of 3: One area that has been changed substantially in the Medical Devices Regulations (MDR) and In-Vitro Diagnostic Medical Devices Regulations (IVDR) over the expiring EU directives is:CorrectIncorrect
Question 2 of 3: How long are the transition periods for medical devices and in-vitro diagnostics under the new regulations?CorrectIncorrect
Question 3 of 3: What year will the Medical Device Regulation come into force?CorrectIncorrect