European Medical Device Directives

Gain market access in Europe by complying with the Medical Device Directives

The Medical Device Directives are 'New Approach' directives relating to the safety and performance of medical devices which were harmonized in the EU in the 1990s. For a manufacturer to legally place a medical device on the European market the requirements of the relevant Directive have to be met and a CE mark applied.

As a Notified Body for CE Marking, our certificates are acknowledged as trusted certificates by authorities, suppliers, and manufacturers around the world. Because of this recognition, certification through us can help you obtain approval in global markets.

The European Medical Device Directives

Any medical device placed on the European market must comply with relevant legislation. Manufacturers' products meeting 'harmonized standards' have a presumption of conformity to the Directive. Products conforming with the Directive must have a CE mark applied. The core legal framework consists of three directives:

All medical devices must fulfil the essential requirements set out in the above mentioned Directives. Where available, relevant standards may be used to demonstrate compliance with the essential requirements defined in the Directives list of harmonized standards.

Revision of the medical device regulatory framework

On 26 September 2012, the European Commission adopted a Proposal for a Regulation of the European Parliament and of the Council on medical devices and a Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices which will, once adopted by the European Parliament and by the Council, replace the existing three Medical Device Directives. Read the proposals and other related documents.

MDD-IVDD communication 2012-540 (48KB) >
MDD Regulation proposal 2012-542 (572KB) >
IVDD Regulation proposal 2012-541 (449KB) >

Conformity assessment route for the Medical Device Directives 93/42/EEC, 98/79/EC and 90/385/EEC

Manufacturers need to determine the appropriate conformity assessment route. For devices falling under Directive 93/42/EEC other than custom-made devices and devices intended for clinical investigation, the conformity assessment route depends on the class of the device, to be determined in accordance with certain rules (see Articles 9 and 11 of Directive 93/42/EEC).

In the case of in vitro diagnostic devices, the appropriate conformity assessment route is determined by lists (see Article 9 paragraph 2 and 3 of Directive 98/79/EC and Annex II).

The appropriate conformity assessment route for active implantable medical devices is determined without reference to classes or lists (see Article 9 of Directive 90/385/EEC).

Why choose BSI for your medical device requirements?

We understand that obtaining certification and compliance can be a long and complicated journey. There are often 'shortcuts' – easier paths to market readiness – that arise, but your organization should never settle for a Notified Body whose focus is on short term solutions.

When you partner with BSI, you’ll benefit from exceptional product and regulatory expertise through our team of dedicated professionals. Our solutions are tailored to your goals to ensure cost-effective certification that stands up to scrutiny and supports your long term goals When choosing us you can rely on our five core values:

  • Product expertise – our diverse and experienced team brings in-depth knowledge and understanding of complex medical device technologies.
  • Global access – we operate in over 180 countries with more than 100 years of experience and offices around the world to serve you.
  • Speed-to-market – providing flexible solutions for manufacturers needing accelerated pathways to global markets.
  • Confidence – our stringent review process combines speed with experience, integrity, independence and predictability.
  • Experience – our expert team has over 1750 years' combined industry and regulatory experience, so we understand the challenges you face.