Since 1998, it has been a regulatory requirement for medical devices offered for sale in Europe to have CE marking affixed. The MDD (93/42/EEC) covers all products which claim to have a medical purpose and which are used in and on the human body. Devices covered by the MDD are grouped into four classes, according to the level of risk they present.
In May 2017 the Medical Device Regulation (MDR) was published. With a transition period of three years from 25 May 2017, it will replace the MDD and bring significant change to the medical device industry. The incoming regulation is three times larger than its predecessor, and aims to strengthen patient safety via a robust, transparent and sustainable regulatory framework that focuses on three key objectives:
Providing patients, consumers and health professionals with confidence in the devices they use daily
Allowing the industry to bring safe, effective and innovative products to market quickly and efficiently
Increasing the availability of innovative companies to attract investors, estimate costs and anticipate procedures
Certificates issued under the MDD during the MDR transition period (26 May 2017 – 25 May 2020) are valid for up to four years from the date of issue.
Certificates to the new MDR can be issued from a designated notified body, with designation expected to take place between 26 Nov 2017 and 26 May 2019
What we offer
Under the Medical Device Directive (MDD), LR is a Notified Body for medical devices using the quality system conformity routes - Annexes II, V and VI.
You will need to complete a simple form letting us know about your company and your products and then we will use this information to verify the requirements relating to your products and by working with you determine the best options for conformity assessment, including any other services we can help you with.
Our gap analysis is an assessor-delivered activity that focuses on identifying the critical, high-risk or weak areas of your system in preparation for certification.
The certification assessment can, if requested, be used to assess the quality system against recognised QMS standards, such as ISO 9001 and ISO 13485.
Once approved, we’ll regularly review your system and sample technical files to ensure its ongoing effectiveness and compliance with the requirements.
What are the benefits?
Safe, high-quality medical devices
The MDD introduced for the first time common regulatory requirements within the European Economic Area (EEA). It specifically deals with the safety, quality and performance of medical devices, aiming to ensure they are safe for use and meet the performance levels specified by their manufacturer.
Why choose LR?
LR has been a leading notified body for over 20 years, and is independently accredited by the relevant accreditation bodies to provide CE Marking to MDD 93/42/EEC and IVDD 98/79/EC. We are actively shaping the medical regulations through our experts’ participation in the Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) technical committees and associations. We also provide input to regulators, including the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK regarding the development of regulatory policies. LR is currently working towards having a full scope as a notified body under the new regulations.
Independent & Impartial
We maintain our independence and impartiality by proactively managing conflicts of interest across all LR businesses including those which may exist between consultancy and third-party certification services. We will not offer consultancy services for any management system that is in the process of or has completed accredited third-party certification with LR. Further, if we are already providing consultancy services relating to a management system, we will not offer any accredited third-party assessment services.
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