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Medical Device Directive (MDD) (93/42/EEC)

Validating the safety of medical devices.

CE marking to the Medical Device Directive (MDD) 93/42/EEC is important if you manufacture or distribute medical devices within the European Economic Area (EEA), as it confirms your medical devices conform with regulatory requirements.

Medical devices
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Overview

Since 1998 it has been a regulatory requirement for medical devices offered for sale in Europe to have CE marking affixed. MDD 93/42/EEC covers all products which claim to have a medical purpose for use in and on the human body; from heart valves to scalpels, excluding in vitro diagnostics which are covered in a separate directive – the exact definition of the products covered can be found within the MDD.

The Lloyd’s Register (LR) Medical Directives team provides guidance on the classification of your device and which assessment route is most appropriate to meet your business needs.

Devices covered by the MDD are grouped into four classes according to the level of risk they present.

  • Class I - Low risk
  • Class IIa - Low-Medium risk
  • Class IIb - Medium-High risk
  • Class III - High risk

On 5 May 2017, the Medical Device Regulation (EU) 2017/745 (MDR) was published in the Official Journal of the European Union. As a medical device manufacturer, you have three years from 25 May 2017 to transition to the MDR. Within this period, manufacturers must update their technical documentation and processes to meet the requirements of the new regulation. Manufacturers can continue placing devices on the market with valid MDD certificates, if there are no significant changes to the device, until May 2024.

MDD Requirements

LR has been assessing to the MDD since 1994. With over 20 years of experience as a Notified Body and holding Notified Body status for over 15 EC product directives, we have in-depth knowledge of certification within the medical device sector, including the MDD essential requirements.

Under the MDD 93/42/EEC Lloyd’s Register is a Notified Body for medical devices using quality system conformity routes – Annexes II & V.

Need help with the MDD?

The two-stage certification process for CE marking ensures you have a quality system that follows the MDD guidelines and meets the requirements of the conformity annex applied and implemented by the manufacturer of the medical device concerned.

Your LR assessor will first establish you have correctly identified the MDD essential requirements that apply to your products, have fully integrated the requirements into your QMS system and have taken the necessary steps to draw up the technical documentation.

Once approved, LR will perform regular surveillance visits to review your system and sample your technical files, helping you remain compliant with the MDD requirements.

Why work with us?

Globally recognised and accredited

Lloyd’s Register has been a leading Notified Body for over 20 years, holding designation from the MHRA to provide CE marking to MDD 93/42/EEC and IVDD 98/79/EC. We are also accredited by United Kingdom Accreditation Service (UKAS) and Standards Council of Canada (SCC) to provide ISO 13485 certification, and by SCC and Health Canada to provide MDSAP certification.

Regulatory expertise

LR is actively shaping the medical regulations and associated harmonised standards through our participation in the Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) technical committees and associations. These include the European Forum of Notified Bodies Medical Devices (NB-MED) and British In Vitro Diagnostics Association (BIVDA).

Streamlined process

By applying LR’s unique inside-out assessment methodology, our technical experts ensure they truly understand your long-term business objectives to reduce organisational risks and enhance effectiveness, efficiency, and continuous improvement of your management systems.

Impartiality

We maintain our impartiality by proactively managing conflicts of interest across all LR businesses including those which may exist between consultancy and third-party certification services. Click here to learn more

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