On May 5, 2017, the EU officially released the EU Medical Device Regulation (MDR). On May 26, 2017, the MDR officially came into effect.
The new MDR regulations will replace the original Medical Device Directive (MDD 93/42/EEC) and Active Implantable Medical Device Directive (AIMDD 90/385/EEC). The regulatory transition period is 3 years, that is, from May 2020 At the beginning, notifying agencies cannot issue CE certificates in accordance with MDD. At present, certification agencies for products with risk levels of I* and above no longer accept applications for certification under the MDD directive.
That's right! The new medical device regulations MDR will indeed replace the old MDD and AIMDD directives!
The notified body no longer accepts MDD directives to apply for CE certificates; CE certificates will be issued after the new version of MDR's regulations and directives are approved. At present, the certification bodies that have this qualification: BSI, TUV South Germany, SGS, etc., have begun to accept matters related to the application for certification of CE certificates under MDR regulations.
CE certification directive for medical devices
1. The main changes of MDR are:
（1）Expanded the scope of application
（2）Proposed new concepts and device definitions
（3）Refine the classification of medical devices
（4）Improve the general safety and performance requirements of medical devices
（5）Strengthen the requirements for technical documents
（6）Strengthen post-market supervision of devices
（7）Improve relevant requirements for clinical evaluation
（8）Proposed the establishment and use of EUDAMED database
（9）Proposed device traceability (UDI)
（10）Put strict requirements on NB
2. the content of changes to the medical device CE certification directive
（1）All notified bodies need to be approved by the EU competent authority before they can conduct audits in accordance with the MDR. This is because before the certification body has obtained the MDR qualification, it is not allowed to issue this type of certificate. The CE certificate issued in accordance with MDD and AIMDD during the transition period will continue to be valid after the official effective date (originally scheduled for May 26, 2020, due to the impact of the epidemic, postponed for one year), but will become invalid after 4 years. At the same time, if the MDD-compliant CE certificate becomes invalid during the transition period, and the MDR-compliant CE certificate is not obtained during the transition period. Then your product must be withdrawn from the EU market until the product obtains the CE certificate that complies with the MDR before it can be re-listed.
（2）In June 2016, the European Commission (EuropeanCommission) issued the fourth edition of the guidelines for clinical evaluation of medical devices (MEDDEV2.7/1 Rev.4). Since the release, many NB institutions have started to implement the new version of the requirements one after another. Some need to provide a new version of technical documents (mainly the clinical report is updated to the fourth version) when applying for new applications, and some need to update technical documents during supervision (there Many companies still follow the third edition before). Therefore, please do not confuse MDR with MEDDEV2.7/1 Rev.4. MDR has not yet learned that there are NB institutions that are officially recognized by the EU to implement the regulations and standards. If enterprises need to apply in accordance with the MDR, they can only follow the MDR regulations. The list is prepared, but the specifics have to wait for the MDR ACT to come out. However, MEDDEV2.7/1 is a guiding principle in nature, so it does not have a so-called "effective date", and each notified body decides on its own the "implementation date" of the third edition. At present, most of the notified bodies no longer accept clinical evaluation reports based on the third edition of the guidelines; products that have previously completed clinical evaluation in accordance with the third edition and obtained CE will also be required to undergo supplementary evaluation in accordance with the fourth edition during the supervision and review.
For companies that have obtained CE certificates, what should they do now?
1) Reconfirm the product risk classification level, and confirm whether there is any risk level upgrade?
For example, some reusable medical devices, which originally belonged to Class I, have become Class I* devices in accordance with the new regulations. Beauty products did not belong to the scope of medical treatment under the original MDD, and are now included in the MDR regulations;
2) Confirm whether the original CE certificate issuing authority has obtained the qualification of issuing MDR certificate approved by the EU authorities, and determine the certification body with this qualification;
3) Confirm whether the original technical file for CE certification contains the clinical evaluation report provided in accordance with Rev4 guidelines;
4) Determine the person in charge of corporate compliance (required by MDR regulations), who has the corresponding ability, qualification and experience to undertake the corresponding legal duties.
5) Modify the original CE technical documents, establish a quality management system, submit an MDR-CE certification application to a certification body with MDR certification qualifications, and obtain a new CE certificate under the MDR regulations.
About Surgaid Medical：
Surgaid Medical (Xiamen) Co., Ltd has been committed to surgical product development ,production and marketing for 10 more years . In particular, minimally invasive surgical products. Minimally invasive surgery is a surgical direction of development. Such as Disposable Laparoscopic Trocar, Linear Cutter Stapler, Circular Stapler, PPH, and so on.
Manufacturing our own Surgical products allows us to have complete control over the design and evolution of our products. We are able to adapt quickly to the constantly evolving healthcare market and offer high quality, single-use, cost-effective solutions that directly compete with global market-leaders.
Surgaid products:
For more product information at https://www.surgaid-medical.com/