Some products come within the 'borderline' area with medical devices.
This means that the regulatory route for a particular product may not be clear immediately and a manufacturer may need to seek advice with respect to the correct route for the product.
Borderlines between medical devices and in vitro diagnostic products can be found in the section on the In Vitro Diagnostic Medical Devices Directive.
Borderline products may be between the medical device regulations and those covering, for example, biocides, personal protective equipment (PPE), cosmetics or medicinal products. Products may also be covered by the Low Voltage Directive or Electromagnetic Compatibility (EMC) Directive.
Determination as to whether or not a product is considered as a medical device will be dependant on its mode of action, the intended purpose of the product and whether or not the product fits the definition of a medical device as specified in Article 1 section 2 (a) of the Medical Device Directive 93/42/EEC.
› MHRA has produced guidance on this matter in Guidance note 20
(108Kb)
Some general guidance has been produced by the European Commission - MEDDEV 2.1/1 (external link)
Specific guidance has been produced by the European Commission covering the borderline with EMC and personal protective equipment - MEDDEV 2.1/4 (external link).
There may also be additional guidance on specific products contained in the Medical device expert group’s ‘Manual on borderline and classification in the community regulatory framework for medical devices’, a copy of which may be obtained from the European Commission’s website.
› Manual on borderline and classification in the community regulatory framework for medical devices (external link)
Where a manufacturer is unsure of the correct regulatory route for a product, further advice may be sought from MHRA or other regulatory authorities. The regulatory authorities that may be contacted are:
Biocides, PPE (Personal Protective Equipment)
Contact: The Health and Safety Executive (HSE)
Tel: 0870 545 500
E-mail: hseinformationservices@natbrit.com
Web: The Health and Safety Executive (external link)
Online biocide guidance is available at: The Health and Safety Executive's Publications section (external link)
Cosmetics, Electromagnetic Compatibility Directive, Low Voltage Directive, Consumer Protection Act, General Products Safety Directive
Contact: The Department for Business Enterprise & Skills (BIS) (formerly DTI and BERR)
Tel: 020 7215 5000
E-mail: enquiries@bis.gsi.gov.uk
Web and online cosmetic guidance: Department for Business Innovation and Skills (external link)
