The Medical Device Coordination Group (MDCG) of the European Commission (EC) issued guidance on certain transitional provisions regarding European Union medical devices regulations.
MDCG on Transitional Provisions
The MDCG is a special advisory body of the European Commission, intended to provide assistance in procedures related to the harmonization and implementation of medical device regulations (Medical Device Regulations 2017/745 and 2017/746 in particular). According to the recent guidance issued by the MDCG, all certificates issued for medical devices in accordance with the previous regulatory framework will be valid until May 27, 2024, as stated in Article 120(2) of the MDR. It was also provided that each notified body would be responsible for post-marketing surveillance procedures regarding the devices certified by those bodies, as stated in Article 120(3) of the MDR. These certification procedures provide conclusions about the contract between the medical device manufacturer and notified body performing assessment procedures. Such contracts also contain provisions regulating post-marketing surveillance. At the same time, post-marketing surveillance performed by notified bodies is overseen by national authorities. It is important to mention that according to the guidance, it doesn’t matter whether the particular notified body applied to be designated under the MDR or not. All monitoring activities conducted by national authorities will be regulated by national laws providing means of empowerment necessary to improve the efficiency of such activities.
Status of Notified Bodies
Notified bodies are entities designated under the MDR to simplify and accelerate medical device certification procedures. In particular, notified bodies will perform conformity assessments, operating in a transparent and impartial manner. An organization applying to be designated as a notified body should employ personnel with knowledge and experience necessary to carry on such functions. According to the new regulatory model set forth by the MDR, all conformity assessments and other procedures related to medical device safety and efficiency examination will be performed by notified bodies while national authorities will conduct general oversight upon the operations of notified bodies. This approach is intended to reduce the time necessary for medical device examination and the expenses associated with it.
According to the European Commission, notified bodies would not upload any information to the NANDO database after May 26, 2020. NANDO (New Approach Notified and Designated Organizations) Information System is a database containing information on the notified bodies designated by national authorities. The information on any particular notified body posted in NANDO includes the identification number of the notified body and its tasks. All information posted in the System should be updated on a regular basis by the national authorities in charge of the designation of notified bodies in accordance with the MDR. After May 25, 2020, the NANDO database would be used for informational purposes only. It would also include information on certain notified bodies designated under the directives acting prior to the MDR, that these notified bodies are no longer entitled to issue certificates unless they are designated under the MDR. At the same time, it would be stated that those notified bodies are still responsible for post-marketing surveillance regarding medical devices certified by them. At the same time, all new submissions will be subject to review by notified bodies designated by national agencies under the MDR.
CAMD MDR Transitional Provisions FAQ
CAMD (Competent Authorities for Medical Devices) is a group formed by the EU national authorities to establish cooperation related to the implementation of new regulations and collaborations on all other issues related to medical devices assessment, marketing and, surveillance. For this purpose, CAMD closely collaborates with the European Commission. The main goal of CAMD is to enhance the level of collaboration of European national authorities.
CAMD issued a detailed review in the form of an FAQ related to the transitional provisions of the MDR and the most important issues associated with it. It contains recommendations on the interpretation of the MDR provisions regulating the transition to the new regulatory framework established by the MDR. The FAQ covers main questions related to the implementation of the MDR, namely:
- The date that the MDR takes effect and when the Directives 90/385/EEC and 93/42/EEC are no longer applicable;
- The way to place a device compliant with the new requirements to the market before the MDR becomes effective;
- The way to place a device compliant with previous Directives to the market before the MDR becomes effective, and how this will impact the validity of certificates issued under the Directives;
- The difference between a “certificate” and a “declaration of conformity”;
- The way to place a device compliant with previous Directives to the market after the MDR becomes effective;
- Additional requirements applicable to Class I medical devices under the MDR;
- Changes in risk-based classification rules related to Active Implantable Medical Devices;
- Details on “sell-off” provision related to the availability of the devices already placed on the market;
- Other important aspects that medical device manufacturers should pay attention to.
Concerning the CAMP FAQ, the guidance issued by the MDCG refers to the explanation of question 17 related to the placing on the market or putting into service medical devices compliance with Directives. In particular, it says that the responsibilities of the notified body regarding the certificates issued, including the surveillance, should be agreed upon between the notified body and medical device manufacturer on a contractual basis.
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