The Medical Device Directive MDD (93/42/EEC) and the Active Implantable Medical Device Directive AIMDD (90/385/EEC) were replaced by the Medical Device Regulation MDR (EU 2017/745). The regulatory transition period is set to 3 years, 2020 It will be enforced on May 26.
After the implementation of the MDR, it is still possible to apply for a CE certificate in accordance with MDD and AIMDD during the three-year transition period and maintain the validity of the certificate. According to Article 120 Clause 2, the CE certificate issued by NB during the transition period will continue to be valid, but the validity period will not exceed 5 years from the date of delivery, and it will expire on May 27, 2024.
However, due to the lack of a designated notification agency, coupled with Brexit and the outbreak of the new crown epidemic, on April 24, 2020, the European Union officially announced that it would postpone the mandatory implementation date of the Medical Device Regulations (MDR) for one year, which made China Medical The device manufacturer gets a buffer time.
However, the expiration date of this extension, May 26, 2021, is also close at hand.
According to the summary of Clifton MedTech Consulting, a medical technology consulting agency, the main changes in the new EU medical device regulation MDR include:
The scope of medical devices has been expanded to include some cosmetic devices that have no medical effect (such as colored contact lenses used for cosmetics).
A central electronic database (called Eudamed) will be set up to collect all relevant information, including operators, announcement agencies, market surveillance and vigilance, clinical investigations, certificates and product information. The EU database EUDAMED will be greatly expanded and open to the public. Improve the transparency and traceability of products to patients.
In the future, each product must contain an independent product identification code (Unique Device Identification, UDI) to strengthen its traceability throughout the supply chain.
The Medical Device Coordination Group (MDCG) has the right to request further scientific evaluation of the product's performance and safety. This procedure is likely to greatly extend the listing process of medical devices.
Competent Authorities and their regulatory notice agencies will adopt more stringent regulations to establish the rights and obligations of these agencies, and each competent authority (ie, the statutory management bodies of each member country) will jointly audit whether the notice agencies comply with the new regulations Require.
For high-risk medical devices such as implantable prostheses, "only the newly established special notified bodies "special notified bodies" have the right to grant CE certificates. Manufacturers will accept surprise audits by certification bodies.
The notifying agency may conduct unannounced inspections of manufacturers.
Clarify the requirements for manufacturers to monitor the quality, performance and safety of the equipment after it is put on the market. Improve the availability and accessibility of clinical data on these devices.
Clinical evaluation and clinical testing will be further standardized and specific requirements will be made. Product aftermarket monitoring needs to be further improved, and clinical evaluations must be updated based on the collected data.
Strengthen the protection of patients participating in clinical investigations.
Strengthen relevant regulations for high-risk equipment. Spinal implants, devices that control and monitor active implants, nanomaterials, non-tolerant devices, and combination products will be classified as Class III devices, requiring technical documents, namely design files.
For higher-risk Class III implantable products and Class IIb active medical products that are used for drug delivery or to remove drugs from patients, the notified body must notify the relevant regulatory agency, the agency or the European Union, during the conformity assessment procedure. The committee makes relevant decisions based on the opinions of experts.
The requirements for the content of product technical documentation have been more detailed specifications than they are now. In the future, there is a need to continuously update the technical documentation.
New requirements are put forward on product labeling.
Unification of business and certificate of notified bodies within the EU (MDR certificate).
The format of the declaration of conformity and technical documents will be revised.
Manufacturers must have qualified personnel (including diplomas and work experience) in the medical field, such as responsible for law enforcement and product market monitoring.
Improve the requirements for the reprocessing process of product reuse.