Guidance for EU MDR – Systems and Procedure packs
Contents 1.
Introduction .......................................................................................................................... 2
2.
Scope and Objective ............................................................................................................. 2
3.
What are systems and procedure packs under the MDD? ................................................... 2
4.
What are systems and procedure packs under the MDR? ................................................... 4
5.
Classification guidance .......................................................................................................... 6 5.a Classification of medical device systems and procedure packs under the MDD ................ 6 5.b Classification of medical device systems and procedure packs under the MDR ................ 7
6.
Checklist for manufacturers of medical device systems/procedures packs (MDR) ............. 8
7.
Examples of procedure packs under the EU MDR .............................................................. 10 Example 1 ................................................................................................................................ 11 Example 2 ................................................................................................................................ 12 Example 3 ................................................................................................................................ 13 Example 4 ................................................................................................................................ 14
8.
Appendices .......................................................................................................................... 15 Appendix A: MDD vs MDR for systems and procedure packs ................................................ 15 Appendix B: Table of relevant documents.............................................................................. 23
Guidance for EU MDR – Systems and Procedure packs
1. Introduction The new EU MDR (2017), with a mandatory compliance date of 26 May 2020, replaces the former MDD (1993), and introduces new concepts, definitions and procedural requirements for medical device systems and procedure packs. Due to considerable advancements in the fields of surgery (particularly in specialised and precise surgical procedures), manufacturing and electronics there are now a much larger range of medical device products that would be considered as systems/procedure packs under the new regulations. Manufacturers of medical device systems and procedure packs, must carefully consider the new rules and regulatory requirements set forth within the EU Medical Devices Regulation 2017/745 (EU MDR), adopted by the European Parliament and Council in May 2017
2. Scope and Objective The aim of this document is to provide guidance regarding the classification and regulatory compliance of systems and procedure packs intended to be used as a medical device in accordance with the EU Medical Device Directive 93/42/EEC (MDD) and the new EU Medical Device Regulation 2017/745 (MDR).
3. What are systems and procedure packs under the MDD?
Guidance for EU MDR – Systems and Procedure packs While the MDD does not specifically define what a system or procedure pack is, it is clear from Article 12 of the MDD that it is the combination or assembly of medical devices that have CE marking approval and are proven to be compatible, considering their original intended use, for a specific medical purpose. If such conditions are met, and the devices will be marketed together as a system or procedure pack then the following applies: 1. The natural/legal person is required to draw up a statement/declaration stating that: •
The mutual compatibility of the devices has been verified in accordance to the manufacturer’s instructions and intended use
•
The system/procedure pack has been packaged with the relevant information supplied from the manufacturers to the user. All the activity regarding combination of devices is subject to the appropriate methods on internal monitoring and control
•
2. For devices designed by their manufacturer to be sterilised before use: •
Follow the procedures set out in Annex II OR Annex V of the MDD. (The scope of these procedures is limited to ensuring sterility until the package is either opened or damaged).
•
The natural/legal person must draw up a statement/declaration that serialisation was done in accordance to the manufacturer’s instructions.
3. Systems/procedure packs do not require an additional CE mark, however they do require: •
Information supplied by the manufacturer as per Annex I (13) of the MDD
•
The statement/declaration referred to above to be kept at the disposal of the competent authorities for 5 years
In the case that the conditions are not fulfilled then Article 11 applies instead, this can be due to: a. One or more of the devices in the system/procedure pack is NOT CE marked b. One or more of the devices in the system/procedure pack IS CE marked but not for the intended use of the system/procedure pack