Medical devices

A central challenge for the medical device and diagnostic/rehab industry is the increasingly tighter regulatory framework - which is becoming so extensive that it is shortly expected to rival the rules governing pharmaceutical companies. Industry regulations are further complicated by the fact that they are mainly based on EU law.

These challenges will certainly not diminish while the market continues to undergo rapid development to produce new types of product, including eHealth and Big Data, and the rate of development outpaces the legislation.

We have many years of experience in assisting suppliers, distributors, EU importers and other businesses in and around the medical device and diagnostic/Rehab industry, and have therefore gained wide-ranging experience concerning medical devices (including in vitro diagnostic devices).

With our in-depth knowledge of the special regulations governing the medical industry, we ensure that our clients comply with complex EU-law requirements and stay on top of new sets of rules for the classification, testing and marketing of medical devices.

Our advice includes:

CE marking, other EU directives, and product and business-related compliance requirements
Contact with the authorities
Sales agreements, terms of sale and delivery, agency and distribution agreements
Procurement, importation, supply agreements
Production, licensing, partnerships and other commercial agreements
Research, development, clinical trials, technology transfers, non-disclosure agreements
Cooperation agreements for medical devices between regions, municipalities and other entities, including private entities.
Exports and activities abroad
Protection and enforcement of IPRs, including patents and trademarks