On 26 May, 2021, the Medical Device Directive (MDD) will be replaced by the new Medical Device Regulation (MDR). MDR is designed to be an improved version of MDD, with the major difference being that MDR influences and provides effectiveness to all EU member states. This allows MDR to provide a regulation which is consistent and fair to all member states, increasing the standards on quality and safety measures.
Not only will the MDR widen to include all 27 EU member states (excluding the UK), but the guidelines included will also urge companies to undertake action and improve on their current product hygiene and safety, thus vastly improving their overall standards.
What does the new MDR entail?
The MDR document is four times longer than the MDD, and puts more emphasis on product safety. Nothing from within the MDD has been removed, rather the MDR has added some new requirements. The regulations within the law require companies to review and improve their portfolios, thus implementing the required changes in order to remain compliant.
Why did the MDD need to be updated?
The MDD came into law in 1992, and is therefore outdated. For example, Software as a Medical Device (SaMD) did not yet exist. Furthermore, apps that patients used to monitor their own health did not yet exist.
The average age in Europe has also seen an increase since 1992, and this brings greater risks in medical device malfunction. To combat this, MDR has put stricter regulations on product life cycle, in order to increase overall product hygiene. Since 1992, people have also become more conscious of their health. With these factors, there has been more demand from the consumer for transparency of medical device technical information (greenlight, 2019).
What can manufacturers do to do prepare for MDR?
Although these changes are set to take effect mid-2021, companies should take action now. Despite these changes applying to Europe, manufacturers all over the world will be adapting to MDR within the next few years. Seeing as delays are likely, it is recommended that companies do not put off strategic changes for too long.
These new laws require companies to overhaul their core processes. This includes the recertification of existing products, to ensure that the new standards are met. The new rules companies will need to abide by include a new standard for technical documentation and labelling. Manufacturers will also need to provide detailed clinical data to prove that safety standards are met. Reporting incidents that did not result in death will also become stricter, with this timeframe being halved from 30 days to 15 days (thefdagroup, 2020).
What testing properties have to be fulfilled by the manufacturer?
The replacement of the MDD by the MDR will be accompanied with an amendment of the DIN EN ISO 10993, the document which regulates the chemical and biological analytics of the manufacturers’ products in 20 independent guidelines. The ISO 10993 regulates the testing strategy of every individual medical device according to its contact time and contact properties (e.g. superficial vs. blood contact or implanted) with a strong bias on the chemical composition, pyrogenic /cytotoxic properties and microbiological contamination.
ISO 10993 clearly indicates that in vitro test systems have to be preferred to animal studies whenever this is possible. Another important aspect is represented by the fact that the manufacturer has to assess the biological safety of defined medical device during its entire life cycle. In this context reusable medical devices have to be assessed according to their validated application cycles.
To offer a maximum of support for the medical device manufacturers Tentamus has implemented a sophisticated test platform covering the entire in vitro testing part of the DIN ISO 10993, in detail
- Chemical characterisation of medical devices (ISO 10993-18)
- Determination of ethylene oxide residuals (ISO 10993-7)
- Determination of cytotoxicity in-vitro (ISO 10993-5)
- Determination of microbiological contamination (Bioburden) and sterility (ISO 11737-1 / -2)
- Determination of bacterial endotoxin and non-endotoxin pyrogens (LAL- und MAT: Ph. Eur. 2.6.14 / 2.6.30)
- Determination of skin irritation in-vitro: ISO 10993-10 (10993-23 (Draft)) / OECD TG 439
- Determination of skin corrosion in-vitro (OECD TG 431)
- Determination of ocular irritation (OECD TG 460)
- Determination of sensitization in-vitro (OECD TG 442d/e)
- Determination of genotoxic effects (ISO 10993-3)
- Determination of hemocompatibility (ISO 10993-4)
An individual testing strategy for each medical device has to be prepared by the manufacturer and presented to the notified body for market registration. The Tentamus group supports manufacturers on the analytical testing requested by a manufacturer having its strategy in place. In case no testing strategy is in place yet, the Tentamus Group supports the preparation of the testing strategy beforehand, in cooperation with consultants. This ensures the safety of both the product and patient.
What new regulations can be found within MDR?
The MDR is not entirely different to the MDD. Although manufacturers will have a lot of work in switching to the MDR, the European standards have been continuously updated in the 25 years the MDD has existed. Novelties within the MDR, are rare. Most of the changes are stricter regulations of previously existing rules.
The following rules however, are new within the MDR:
- At least one person within an organization is required to ensure the regulatory compliance of the business (many business already have a quality or regulatory compliance or safety manager, so this isn’t a new regulation to many) (eumdr, 2017).
- Products without an intended medical purpose will also be included in the MDR. This is specified in Annex XVI, which covers items intended for cosmetic purposes.
Within the new MDR, 16 Annexes are attached. Annex XVI in particular has raised concern with the manufacturers of cosmetic goods. This annex is focused on products without an intended medical purpose, and seeks to impose new guidelines that aim to protect the consumer.
The following products now have regulations pertaining to safety and health:
- Coloured, non-corrective contact lenses or other items that are applied directly to the eye
- Products that must be inserted into the human body through surgical means to modify anatomy or fixate body parts. Ex. Cosmetic horn implants
- Substances, or items to be used for facial or nasal cosmetic purposes. Ex: dermal fillers.
- Equipment intended to aid in the reduction of adipose tissue. This equipment includes tools used for liposuction or lipolysis.
- High intensity electromagnetic radiation emitting equipment used on human skin, including tattoo or hair removal, skin resurfacing, or other skin treatment.
- Equipment used to penetrate the skull in order to modify neuronal activity using electrical currents or electromagnetic fields (transcranial magnetic stimulation)
The European Commission reserves the right to update this list, in order to ensure quality control if new cosmetic products enter the market place in the upcoming period (MHRA, 2017)
What effect does the MDR have on products with CE markings?
In order to market medical devices in the EU, a CE mark certificate is required. This certification confirms that a product has met all regulations in place for medical devices. When the regulations come into play on May 2020, only those who comply with the MDR will attain this certification. However, given that a CE accreditation lasts for 5 years, the last ones to expire under the MDD regulations will do so on 25 May, 2024.
The changes introduced in the MDR affect a variety of aspects in the CE marking process. Some of these processes include device classification, technical file documentation, and post-market activities. The goal of this is to increase the qualitative standards of medical devices within the EU, ensuring improved levels of safety whilst encouraging innovation (kolabtree, 2017).
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