Medical device regulations (MDR)
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medical device regulations (MDR) overview
Medical Device Regulations (MDR) refers to a set of regulations which regulate the production and distribution of medical devices in Europe. These came into force in mid-May 2021 with the aim of streamlining the various fragments of regulations of directives and regulations that previously existed. As with all legal regulations, MDR compliance is a legal requirement for all medical device companies that wish to market or sell their products within the European Economic Area (EEA). Yet, achieving compliance does not simply allow your company to get medical device approval from regulatory bodies, but also ensures that medical devices are safe to be used on patients.
medical device regulations (MDR) overview
Medical Device Regulations (MDR) refers to a set of regulations which regulate the production and distribution of medical devices in Europe. These came into force in mid-May 2021 with the aim of streamlining the various fragments of regulations of directives and regulations that previously existed. As with all legal regulations, MDR compliance is a legal requirement for all medical device companies that wish to market or sell their products within the European Economic Area (EEA). Yet, achieving compliance does not simply allow your company to get medical device approval from regulatory bodies, but also ensures that medical devices are safe to be used on patients.
Benefits of medical device regulations (MDR) compliance
MDR compliance is a legal obligation which carries a variety of benefits, both for your business and your stakeholders. These are a few of the inherent compliance benefits you may expect:
Safe and Effective Products
Increase Transparency
Higher Sales
Pass Your Audits
Medical Device Regulations (MDR) Certified Expert
Being a Medical Device Registered Person (MDRP) with the Medicines Authority, Luke specialises in the compliance for medical devices. Combining his expertise in management systems with his knowledge of Medical Device Regulations (MDR), Luke has never failed to help his clients achieve compliance. He holds over 12 years of experience in the implementation of standard management systems, and has worked on both Medical device regulations (MDR) and in-vitro diagnostic regulations since before their launch in May 2021 and 2022 respectively.
Instead, hiring an expert consultancy with years of experience is the best way to effectively meet your ISO standards. Make sure to choose an expert you trust, to provide you with a grounded approach that will simplify your life, rather than over-complicate it.
GET YOUR JOURNEY TO ISO CERTIFICATION FUNDED
As a Malta Enterprise approved advisor, Luke can help his clients reap the full benefits of currently available funding. Applicable to any business based in Malta, the Government of Malta’s current funding schemes have never been better. The precise amount depending on your company’s size and ownership structure.
For more information, simply get in touch for a free consultation session! Luke will help you to make the most of the best available funding incentives applicable to your business.
RECEIVE FUNDING FOR YOUR JOURNEY TOWARD REGULATORY COMPLIANCE
Funding Opportunities
For pioneering companies, getting ISO 9001 certification is a crucial milestone. Recognizing the importance of working towards this standard, there are various funding opportunities to be found in Malta. These include:
- 50% Tax Credits by the Government of Malta.
- cash grants by Malta Enterprise, JobsPlus, & other entities.
A Closer Look At Medical Device Regulations
What is eudamed?
One of the key aspects of the new rules on medical devices is the creation of a European Database on Medical Devices (EUDAMED). This has been created with the purpose of improving transparency and the coordination of information relating to the medical devices available on the EU market.
Essentially, this online platform is aimed at placing all EU organisations that form part of the Medical Device industry onto the same platform.
One of the key aspects of the new rules on medical devices is the creation of a European Database on Medical Devices (EUDAMED). This has been created with the purpose of improving transparency and the coordination of information relating to the medical devices available on the EU market.
Essentially, this online platform is aimed at placing all EU organisations that form part of the Medical Device industry onto the same platform.
Who should register with Eudamed?
There are various organisations that are obliged to register onto the EUDAMED system, namely:
- Manufacturers – a natural, or legal person who manufactures or fully refurbished a device or has a device designed, manufactured, or fully refurbished, and market that device under its name or trademark (Article 2 – section 30).
- Authorised Representatives – means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this Regulation (Article 2 – Section 32)
- Importers – means any natural or a legal person established within the Union that places ad device from a third country on the Union Market (Article 2 – section 33)
- Systems and Procedure Pack producers – combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack (Article 22 (1)).
- Distributors – any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting it into service (Article 2 – Section 34).
Medical Device Regulations Articles
Frequently Asked Questions
What is the Medical Device Regulation (MDR)?
The Medical Device Regulation (MDR) has replaced the EU’s Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).
When was the Medical Device Regulation implemented?
The MDR came into force in mid-May 2021.
How do I conform to Medical Device Regulation?
Initially, it is important to familiarise yourself with the requirements and deadlines of the new MDR. Additionally, you will need to perform assessments and internal audits to analyse your current systems and identify whether these need to be updated in order to suit the new regulations. Through consultations and training, Luke will help you to achieve conformity and pass your certification audit.