Medical Devices

Medical devices are essential for delivering good care. The definition of medical devices is very broad and ranges from wheelchairs and plasters to implants and CT scanners. Software and health apps may also qualify as medical devices. The quality, security and access to the market of medical devices are enshrined in national and European laws and regulations. These legal rules apply to manufacturers, importers, distributors and agents, among others.

Implementation of Medical Devices Regulation

Due to the corona pandemic, there has been a postponement of the implementation date of the Medical Devices Regulation or “MDR”, which will replace the Medical Devices Directive from 1993. The MDR has entered into force on 26 May 2021. The date when the new In-Vitro Diagnostics Regulation (“IVDR”) will enter into force remains 26 May 2022.

Eline Lam has prepared a handy overview of the main changes the MDR will bring for manufacturers, distributors and health care institutions. You can download this overview here.

Health Care Team

Fenna van Dijk and Eline Lam have a thorough knowledge and experience in the field of medical devices. The team advises on questions about access to the market, licences, clinical research, and questions about inducements, labelling and advertising. They assist manufacturers of medical devices in drafting contracts with customers, or with doctors who cooperate with the manufacturers. For an overview of their recent work, see 'Recent Work' at the bottom of this page.

A special feature of the Health Care Team is that they can offer advice on medical devices from various perspectives. Fenna and Eline work closely together with the specialists in the Commercial & International Trade Team as far as international products of medical devices manufacturers are concerned. Our Insurance and Liability practice group advises and litigates regularly about product liability. Besides, our Insurance and Liability specialists offer a special service in the field of product recalls. We will cooperate with our colleagues from the IT practice group if we are dealing with the interface of software, artificial intelligence and medical devices. Moreover, we also cooperate closely with the Life Sciences team where the regulatory framework of medicines and cosmetics is concerned. In matters concerning tendering procedures for medical devices, we cooperate with our Public Procurement team.

Fenna van Dijk and Eline Lam have contributed to the International Comparative Law Guide – Drug & Medical Device Litigation.

This publication is relevant to you if you are dealing with:

• The development of medical devices, medicines and cosmetics;
• Questions from supervisory bodies;
• The impact of advertising codes on your business operations;
• The effect of the GDPR and other privacy regulations;
• The performance of clinical trials;
• Recalling a defective product (product recall).

The special focus of this publication is on product liability and claims.

You can find the publication in English on the website of ICLG:

• Advising a Dutch non-governmental organization about an app produced by them in light of the regulations under the MDR.
• Advice about the qualification of software and applications of artificial intelligence as medical devices.
• Assessing agreements of suppliers of medical devices and hospitals.
• Advice about a tendering procedure for the purchase of medical devices.
• Drafting agreements with doctors and advice about incentives.
• Advice about labelling of medical devices, medicines and cosmetics.
• Drafting general terms and conditions for a manufacturer of medical devices.
• Guidance of restructuring operations and acquisitions of international manufacturers of medical devices.
• Guidance of the construction of new housing for a manufacturer of medical devices.