Some medical devices consist of substances that are absorbed by the human body to reach their destination. As part of the compliance strategy, manufacturers must also demonstrate basic Good Manufacturing Practice (GMP).5,6 GMP or formal quality systems apply to class IS, Im, IIa, IIb and III devices, AIMDs and IVDs listed in Annex II, and devices for self-testing. Class I basic medical devices (unmeasured and non-sterile) and general IVDs (IVDs not intended for self-testing and/or not listed in Annex II) do not require a formal or complete quality system, basic GMP is sufficient. The EMA is responsible for assessing the quality, safety and efficacy of centralised marketing authorisation applications, including the safety and performance of a medical device as regards its use with a medicinal product. DNV can help you through the entire process, from training to preparation for certification and the certification process itself, through all market access standards and ISO 13485 (Medical Device Quality Management System). A conformity assessment procedure shows that the product satisfies the requirements of Directive 93/42/EEC.2 Conformity must be demonstrated by drawing up a declaration of conformity. The classification of the product determines the appropriate conformity assessment procedure. In some cases, the manufacturer has the choice between the compliance pathway. The conformity assessment pathways are illustrated in Figures 1, 2, 2, 33 and 44. Examples of medical devices containing a drug additive include: Changing Medical Device Legislation, find out what you need to know if you are a manufacturer.
Regardless of the product class, all products must: Regulation EU 2017/745 on medical devices (MDR) was an important update to the medical device regulation introduced in 2017. The MDR replaces the former EU Medical Device Directive (MDD) and aims to modernise the EU regulatory system to better respond to current market requirements and new technologies. Products that have received the CE marking under the MDD can continue to be marketed in the EU, but must be recertified MDR by a notified body before 2024. The MDR contains 22 classification rules, including four new rules and numerous updates to existing rules. Manufacturers need to review the classification of existing devices under the MDR and may find that some devices need to be «highly classified», resulting in more stringent regulatory requirements. In particular, Rule 11 requires the attention of any manufacturer possessing a device containing software. Software that plays a role in decision-making or patient monitoring will be upgraded from a Class I device to a Class IIa device. For more information, see our recent article on software as a medical device. The different elements of the CE marking must have essentially the same vertical dimension, which must not be less than 5 mm, although this minimum dimension may be omitted for small products. For more information on the consultation process for obtaining a scientific opinion from the EMA, see Consultation procedure for auxiliary medicinal products in medical devices. The competent national authorities classify borderline products either as medicinal products or, for example, as medical devices.
This determines the applicable regulatory framework. There are common boundaries between medicines, medical devices, cosmetics, biocidal products, herbal medicines and food supplements. This compliance pathway is similar to that of class IIb devices, but also requires the manufacturer to submit the design documentation to the NL for approval as part of a full quality system audit (Annex II) and does not allow the Annex VI option. The requirements when a manufacturer wishes to apply for authorisation of a new medical device by demonstrating its equivalence with a device already on the market will be strengthened. This makes it less easy for «me too» devices to get approval on the back of data from other devices. However, it should not protect against revolutionary devices. It also makes it more difficult to transfer data from compassionate use programs. In some cases, this has been used as a backdoor for assessment by a notified body, bypassing stricter clinical trials.
During a number of transitional periods, manufacturers can choose to continue to comply with the current Directive or to opt for early compliance with the applicable Regulation. In order to complete the transition to the new regulatory system, notified bodies need to be in place and a new electronic platform (Eudamed) needs to be operational. This work can only be completed at the end of the transitional period. Active implantable medical devices (AIDs) and in vitro diagnostic medical devices (IVDs) are also subject to compliance procedures. DNV is designated by the Norwegian health authorities and the European Commission as Notified Body 2460 for Regulation (EU) 2017/745 (MDR). The designation will be awarded to all requested types of technology, including the most risky Class III devices, to ensure continued access to the European market for our customers` life-saving medical devices. The main objective of the new regulation is to strengthen protection against the risks posed by medical devices and to update the rules to take due account of new technologies. The main themes of the MDR are: In addition, the Medical Devices Regulation (Regulation (EU) 2017/745) provides that expert groups also provide ad hoc advice to the European Commission, the Medical Device Coordination Group, national competent authorities of EU Member States, notified bodies and manufacturers of medical devices where necessary. The medical device may be packaged with the medicinal product, separately from it or as an integral part of the medicinal product. For certain high-risk devices, the Regulations on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746) require notified bodies to consult expert groups before issuing an EC certificate.
According to the MDR, a manufacturer must designate a single qualified person to ensure compliance with regulatory requirements. In addition, each authorized representative must have their own CRRP. To support the implementation of the MDR, updated guidance on quality requirements for medical devices in medicinal products for human use containing a medical device and updated questions and answers are being prepared and will be published shortly. The MDR was published on April 5, 2017. Medical devices can currently be MDR certified, but not all products need to be MDR certified by May 25, 2024. This is a mark of conformity that all European medical devices must have before they can be placed on the market. It shall be considered as a declaration by the manufacturer that the product complies with all relevant provisions of the applicable legislation and, where applicable, has been assessed in accordance with them. Article 1 of MDD 93/42/EEC states: Medical devices have been regulated in a coordinated manner throughout Europe since the 1990s. At that time, the first European Medical Device Directives (MDDs) were published in 1990 and 19933,4.
Over the past decade, there have been a number of scandals involving patients harmed by treatment with approved medical devices. These include the Poly Implant Prosthesis (PIP) breast implant scandal, controversies surrounding metal-on-metal hip replacements, and complications following vaginal mesh implantation. Although the PIP breast implant scandal appeared to be more of a case of fraud than a failure of approval procedures, the notified body responsible for assessing the conformity of the product was held liable for damage resulting from failures in the manufacturer`s control5. These must be submitted in order to assess conformity with the essential requirements of the Directive. The level of detail and complexity depends on the conformity assessment process. Overall, it should cover the design, manufacture and intended operation of the product. The «operation» of the product includes installation, preparation for use, pre-use testing and servicing, calibration and maintenance according to the medical device in question. Sufficient data to demonstrate that the product operates safely and meets the stated performance requirements for its intended use shall be provided. Technical documentation should include: To facilitate your migration to MDR, we have prepared the following visualization of the certification process and important information about the different types of activities.
Note: This is an indicative and non-exhaustive list of requirements.
