The European Commission has put another item on its already long list of guidance documents for medical device manufacturers.
MDCG 2021-24, Guidance on classification of medical devices, will probably be among the set documents for all those who are involved in regulatory affairs around medical products.
The 57-page paper is structured similarly to its predecessor under the medical devices directive (MDD). Sections 1 to 3 provides general information about the context of the guidance and also references important definitions and principles of the classification system.
Section 4 then includes flowcharts for the application of classification rules, but it also provides general explanations and examples for each rule.
Here are some examples of interesting changes/ aspects where the document raises topics of concern. Please note that these are product specific – depending on the product range, further issues may be relevant:
- Section 3.1.5 on active medical devices expands the previous MEDDEV wording and also specifically includes devices like elastomeric pumps as examples.
- Reusable surgical instruments are clearly assigned to rule 6. Examples are scalpels, reamers, drill bits, saws, forceps, etc. It thus seems as if the guidance strengthens the position that reusable instruments or devices that are not clearly surgical do not fall into this category. The latter would be exempt from notified body certification. At the same time, these products may not make use of the extended transition period until May 2024.
- Ultrasound gels will continue to fall under rule 1 and thus will not require a notified body under the MDR.
- Section 4 on rule 8 contains potentially controversial explanations regarding spinal implants where devices that were previously assumed to be class IIb devices could be interpreted to fall into risk class III.
Should you wish us to provide you with the guidance document or should you have any questions, please don’t hesitate to get in touch. Please feel also free to visit our library section for this and other potentially relevant documents.
Source: European Commission
Accompanying this subject we recommend the following content on our website
- bsi article on clinical evaluation requirements under the MDR
- Standard ISO 20417:2021 for the MDR and IVDR published
- EU clearance for MDR and IVDR harmonised standards
- mdi Europa experience on MDR technical documentation reviews
- Supportive Information Section MDR
- Browse by category “MDR”