Global Certification

On May 5, 2017, the MDR medical device regulation 2017/745/EU was officially published in the official journal of the European Union to replace the old MDD medical directive 93/42/EEC and AIMD active implantable medical device Directive 90/385/EEC, and was enforced on May 25, 2020 (effective date: May 26, 2017, transitional period: three years). 

Table 1 - Summary of time points of MDR transition period

Note that the original EU regulatory framework for medical devices consists of medical device directive (MDD) 93/42/EEC and active implantable medical device directive (AIMD) 90/385/EEC. The amendment combines the two directives (MDD & AIMD) and is implemented as a regulation rather than an instruction. The choice to implement as a regulation is that it provides clear and detailed rules that do not divide the use of Member States and ensure that legal requirements are implemented at the same time throughout the EU.

The purpose of MDR medical device regulation is to establish high standard quality and safety standards for medical devices, to meet the general safety problems of these products, to provide high level health protection for patients and users, and to ensure the free circulation of medical devices in the single market of the EU.

MDR covers not only all products covered by MDD and aimdd, but also equipment specifically used for cleaning, disinfection or sterilization of the device, and products listed by annex XVI for unexpected medical purposes, such as meipupil, facial filling or injection, tattoo, skin improvement and beauty.

1. some combination products of medicine and instruments are included. Please refer to article1 (8, 9) for details.

2. contains certain products manufactured by non active or processed non active human derived tissues or cell derivatives.

3. contains specific product groups that claim to have cosmetic purposes only or another non-medical purpose but are similar to medical devices in terms of function and risk characteristics

4. declare that nanomaterial devices are within MDR scope and shall accept the most stringent evaluation procedure.

5. including instruments and medical software for emitting ion radiation.

The classification related in MDD is the index IX in 93/42/EEC and the corresponding guide medev 2.4/1 rev. 9; Article 51 and annex VIII in the new MDR elaborate the classification information of the products. The main change was from "18" of MDD to "22" of MDR.

Rule1 Rule 4: non invasive devices

Rule3: human cells, tissues, trachea for use in vitro directly from human body or human embryo are added, and then implanted or injected into the body. Such devices are class III.

Rule 5-rule 8: invasive devices

Rule 8: on the original basis, the active implant or its related accessories, breast implants or heart repair mesh fabrics, complete or partial joint replacement, and the disc replacement implants directly in contact with the spine are class III.

Rule 9 Rule 13: active devices

Rule9: on the basis of the original, the "active device for the release of ionizing radiation for treatment purposes" and "active implantable devices for control, monitoring or direct impact" are added. Both of these two types of devices are class II B.

Rule11: newly added, software for providing decision information for diagnosis or treatment purposes and monitoring physiological process is class II A; other software classes are class I.

Rule 14-rule 22: special rules

Rule14: further improve the classification requirements for "medical products derived from human blood or plasma".

Rule 18: further improve the classification requirements for "instruments made from non active or processed non active human or animal derived tissues or cells or other derivatives".

Rule19: Add classification requirements for nanomaterials devices.

Rule20: added classification of invasive devices associated with body orifices by inhalation.

Rule 21: the device for introducing the absorbable substances into the human body is added.

Rule22: classification of active therapeutic devices with integrated or combined diagnostic functions has been added.

In addition, the separate classification of blood bags in MDD was deleted.

Requirements of technical documents

The requirements for technical documents are added to MDR, and it is clearly pointed out that post market regulatory plan and safety update report (PSUR) are part of technical documents, and the corresponding information in technical documents is required to be updated according to the data collected by the post market supervision system.

Basic contents of technical documents

1. device description and performance index

2. including the variant and accessories, including the device description and performance index, as well as the information of the previous generation and similar devices quoted.

3. information provided by the manufacturer

4. design and manufacturing information

5. general safety and performance requirements

6. include the supporting materials that meet the general safety and performance requirements provided in Appendix I.

7. risk benefit analysis and risk management

8. product verification and confirmation

9. PRE clinical and clinical data (including clinical evaluation plan / report, PMCF plan / report); and additional information on the devices prepared for drug containing devices, human / animal origin organizations or derivatives thereof, devices introduced into the human body and absorbed, instruments with measuring function, etc

Strengthen the supervision system after the listing of the device

Chapter VII post mark surveillance, virgin and market surveillance emphasize post-market surveillance, which focuses on post Listing Supervision, vigilance and market supervision.

1. establish, implement and maintain the post market supervision system (see article83).

2. emphasize that the post IPO regulatory system runs through the whole life cycle and constantly updates.

3. establish the "post market supervision plan" (see article84), see Annex III for details.

4. Prepare "post market supervision report" for class I devices (see article85).

5. Prepare "PSUR" (see article86) for class IIa, IIb and III devices.

6. PSUR needs to be updated regularly and be part of the technical documents.

7. establish an electronic system for alert and post market supervision (see article92).

8. during the whole service life of the device, the clinical evaluation and technical documents were updated according to the clinical data obtained after PMCF was implemented (Annex XIV Part B).

OViS tells you to improve the requirements of clinical evaluation

The new regulations propose:

1. it is required to implement, evaluate, report and update clinical evaluation data according to article 61 and appendix XIV part a;

2. the opinions of the advisory panel should be considered in cert for specific class III and IIB devices;

3. clinical research is proposed for implantation and class III devices;

4. cert is required to obtain data according to PMCF for updating;

5. for class III and implantable devices, the frequency of CER update is proposed;

6. to clearly prove the characteristics of substantive equivalence to be considered;

7. ask for its interaction with risk management

Propose the trace ability of the device (UDI)

1. besides customized and research instruments, UDI system shall be established for other devices;

2. UDI information is embodied in label or package (excluding container);

3. UDI-DI information shall be specified in the declaration of conformity (see article 27);

4. Annex VI Part B proposes the information contained in UDDI Di;

5. UDI of implantable, reusable, software and configurable devices has special requirements (see Annex VI Part C)

6. see article123 (f) for the time of implementation of UDI on the package or label.

7. The UDI issuing entity is designated by the European Commission.

8. transitional: Article 120 states that "GS1, HIBCC and ICCBBA shall be deemed to be designated issuers until the board designates the issuing entity in accordance with Article 27 (2).".

Strict requirements for NB proposed by new EU MDR certification

For the "bulletin body", the new MDR will spend a large amount of time describing its functions and requirements; each NB shall reapply the authorization for the tripartite audit of MDR in accordance with appendix VII