When is a medical device considered a medical device and when it isn't? Although there is a clear definition for medical devices in the EU Directive (93/42/EEC), practice shows that there are time and again areas of confusion with regard to medicinal products or cosmetics. In a 12-page guideline entitled "Borderlines with medical devices", the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) tries to give assistance. In the following, you will find a summary of the guideline.
The guideline contains 12 pages divided in 23 chapters. Considering the number of chapters, it is obvious that some of them are very short. By the way, the guideline is the continuation of the version 1.0 from February 2014.
The introduction (Chapter 1) points out that a product considered a medical device in the USA, Canada or Japan is often considered as such by manufacturers in Europe. Yet, this is not always the case and that's why it should always be referred to the definitions laid down in the European guidance documents listed in Chapter 23 when questions about medical devices arise. In the case of doubts, the MHRA should be consulted as the guideline only addresses general cases.
Chapter 2 details the medical purpose of medical devices.
The subsequent chapters 3 to 10 and 12 give a list of examples (cosmetic, toiletry purpose, general purpose and assistive products, sports and leisure, personal protective equipment, Software, machinery, accessories) which may be confusing. They are also partly compared to medical devices. Regarding the borderline with medicinal products, it is referred to a specific guideline (chapter 11).
In the chapters 13 to 16, the particularities of starting materials, components, spare parts as well as second-hand and fully refurbished devices are covered.
Chapter 17 deals with final processing of medical devices on site. Chapter 18 and 20 address custom-made devices and in-house manufacturing (for example in hospitals). A specific chapter (N° 19) is dedicated to questions regarding kits falling under the scope of Article 12 of the Medical Devices Directive. Borderlines with biocides (medicinal products vs. medical device vs. biocides) are presented in Chapter 21, whereas other borderlines are addressed within 4 lines in Chapter 22. At the end of the document, you can find a list of guidance documents (MHRA and guidelines from the European Commission (MEDDEV)) in Chapter 23 and an appendix of words and phrases.
Conclusion: The guideline is a British guideline. For those interested in borderline cases and examples of them, the document may be useful and is easy to read. In-depth information can be found in the references to the EU guidelines listed in Chapter 23.
For more details please also see the guideline "Borderlines with medical devices".