The new MDR will replace the currently valid medical device directives (MDD and AIMDD) on May 26, 2021. A corresponding amendment to the German MPG is also available as the Medical Devices Amendment Act. The exact aspects of the MDR, which have to be checked in the context of surveillance procedures according to MDD, are for example presented in the transition rules in Art. 120 MDR. If these requirements are not met by a manufacturer after 25.05.2021, this constitutes a deviation from the applicable legal requirement. In particular, the requirements of Art. 120 (3) MDR are to be implemented in the QM system of a guideline manufacturer:

1. post-market surveillance (PMS).

2. vigilance (incident reporting)

3. registration of economic operators and products

1. Post-market surveillance (PMS)
To post-market surveillance MDR primary reference to the requirements on a PMS system laid out in Articles 83 to 86 MDR and Annex III MDR. The manufacturer shall plan the PMS system. For class I medical devices, a PMS report must be prepared if necessary; this report must be submitted to the market surveillance authority upon request (Art. 85 MDR). For higher class medical devices (IIa, IIb and III) a Periodic Safety Update Report (PSUR) shall be prepared (Art. 86 MDR); this shall be submitted to the Notified Body. Deadlines for regular updating and submission are specified depending on the risk class: annually for class III and IIb devices, every two years for class IIa devices. In addition to assessing the impact on the risk-benefit balance, these reports shall also include information on where the devices are placed on the market. Details on the content of the reports are specified in Articles 85 and 86 MDR.

2 Vigilance
Requirements on incident reporting have been tightened in Article 87 MDR. On the one hand, the Europe-wide standardized reporting deadlines replace the previous reporting deadlines:

• 2 days for serious risk to public health.
• Serious incident: Immediately, but no later than 15 days.
• Death or unforeseen serious deterioration of health: immediately, but no later than 10 days.

On the other hand, requirements for summary reporting (Periodic Summary Reporting – Art. 87 (9) MDR) as well as trend reporting (Art. 88 MDR) for expected adverse events or non-serious events are specified. As soon as the EUDAMED database is operational it shall be used for the reporting process.

3. Registration of economic operators and products.
Requirements for registration of products under the MDD are detailed in MDCG 2019-5. Registration of legacy devices shall be completed within 24 months (6 + 18 months) after availability of EUDAMED. However, in the case of incidents or field safety corrective actions (FSCA) reportable via the EUDAMED portal the registration has to be considered before the end of the transition period in order to facilitate the incident report. The obligation to register devices subsequently results in the obligation to register the respective manufacturer or authorized representatives according to national requirements. The general opinion is that the Responsible Person (Art. 15 MDR) must be implemented from the date of application of the MDR, i.e. from 25.05.2021.

Validity of directive certificates from the date of application of the regulation
For certificates according to Dir. 90/385/EEC (AIMDD) Dir.93/42/EEC (MDD) or Dir.98/79/EC (IVDD) the respective validity dates and conditions apply (e.g. connection between certificates according to Annex II.4 and the certificates according to Annex II without 4). However, after expiry of the transition periods to the MDR (2021-05-26) as well as to the IVDR (2022-05-26) certificates according to the directives (AIMDD, MDD and IVDD) can no longer be newly issued or amended. However, Art. 120 (3) MDR or Art. 110 (3) IVDR define that for maintaining the certificates of such products, no significant changes in design or intended purpose may be implemented. A substantial change after the end of the transition period to a product that is placed on the market on the basis of a certificate according to one of the two directives (MDD or IVDD) will result in void of the original certificate. i.e. the change and subsequently the entire product must be subjected to a certification procedure according to MDR. However, this does not affect the obligation to notify changes to the Notified Body. MDCG has published a guidance document (MDCG 2020-3) which sets out which changes are interpreted as “significant change” under the MDR. This document must be used as the basis for evaluating any change for impact on existing certification after the end of the transition period.